Study Description

PRIMARY OBJECTIVES:

I. To identify the dose of pazopanib that is feasible when given in combination with radiation or chemoradiation in pediatric and adult patients newly diagnosed with unresected intermediate- and high-risk non rhabdomyosarcoma soft tissue sarcomas (NRSTS).

II. To compare the rates of near complete pathologic response (> 90% necrosis) with the addition of pazopanib to preoperative chemoradiation versus preoperative chemoradiation alone for potentially resectable > 5 cm, grade 2 or 3 intermediate to high risk chemotherapy-sensitive NRSTS in the phase II portion of the study for this cohort.

III. To compare the rates of near complete pathologic response (> 90% necrosis) with the addition of pazopanib to preoperative radiotherapy versus preoperative radiotherapy alone for potentially resectable intermediate to high risk adult and pediatric NRSTS in the phase II portion of the study for this cohort (using a phase II decision rule to go onto the phase III portion of the study).

IV. To compare the rates of event-free survival (EFS) with the addition of pazopanib to preoperative radiotherapy versus preoperative radiotherapy alone for localized intermediate to high risk adult and pediatric NRSTS in the phase III portion of the study for this cohort if the phase II decision rule is passed.

SECONDARY OBJECTIVES:

I. To estimate the rates of local failure, regional failure, distant metastasis free survival, disease-free survival, and overall survival with the addition of pazopanib to preoperative chemoradiation or preoperative radiation in intermediate to high risk adult and pediatric NRSTS.

II. To compare the pattern of recurrence (local, regional and distant) between preoperative chemoradiation or radiation with the addition of pazopanib for adult and pediatric NRSTS.

III. To define the toxicities of ifosfamide and doxorubicin chemotherapy and radiation when used in combination with pazopanib in intermediate to high risk adult and pediatric NRSTS.

IV. To define the toxicities of preoperative radiotherapy when used in combination with pazopanib in intermediate to high risk adult and pediatric NRSTS.

EXPLORATORY OBJECTIVES:

I. To gain insight into the disease biology of childhood and adult NRSTS through analysis of actionable mutations and whole genome sequencing.

II. To determine if microvessel density and circulating tumor deoxyribonucleic acid (DNA) predict response to pazopanib and outcome.

III. To determine the effect of pazopanib on doxorubicin exposure in children and adults with NRSTS.

IV. To evaluate change in fludeoxyglucose F 18 (FDG) positron emission tomography (PET) maximum standard uptake value (SUVmax) from baseline to week 10 or 13 in patients with unresected tumors and to correlate this change with pathologic response and EFS.

V. To compare the rate of response by standard imaging and pathologic assessment to determine which correlates better with local tumor control, distant tumor control, EFS, and overall survival.

OUTLINE: This study starts as a dose-escalation study of pazopanib.

CHEMOTHERAPY COHORT: Patients eligible for chemotherapy cohort are randomized to 1 of 2 treatment regimens.

REGIMEN A:

INDUCTION PHASE: Patients receive pazopanib orally (PO) once daily (QD) on weeks 1-12, ifosfamide intravenously (IV) over 2-4 hours on days 1-3 on weeks 1, 4, 7, 10, and doxorubicin IV over 1-15 minutes on days 1-2 on weeks 1 and 4. At least 24 hours after the completion of week 4 doxorubicin, patients undergo radiation therapy on weeks 4-10.

SURGERY: Patients undergo surgery on week 13.

CONTINUATION PHASE: Patients receive pazopanib PO QD on weeks 16-25, ifosfamide IV over 2-4 hours on days 1-3 on weeks 16 and 19, and doxorubicin IV over 1-15 minutes on days 1-2 on weeks 16, 19, and 22. If applicable, patients undergo additional radiation therapy at week 16

REGIMEN B:

INDUCTION PHASE: Patients receive ifosfamide IV over 2-4 hours on days 1-3 on weeks 1, 4, 7, 10 and doxorubicin hydrochloride IV over 1-15 minutes on days 1-2 on weeks 1 and 4. At least 24 hours after the completion of week 4 doxorubicin, patients undergo radiation therapy on weeks 4-10.

SURGERY: Patients undergo surgery on week 13.

CONTINUATION PHASE: Patients receive ifosfamide IV over 2-4 hours on days 1-3 on weeks 16 and 19 and doxorubicin IV over 1-15 minutes on days 1-2 on weeks 16, 19, and 22. If applicable, patients undergo additional radiation therapy at week 16.

NON-CHEMOTHERAPY COHORT: Patients eligible for non-chemotherapy cohort are randomized to 1 of 2 treatment regimens.

REGIMEN C:

INDUCTION PHASE: Patients receive pazopanib PO QD on weeks 1-9. Patients undergo radiation therapy on weeks 1-7.

SURGERY: Patients undergo surgery on week 10.

CONTINUATION PHASE: Patients receive pazopanib PO QD on weeks 13-25. If applicable, patients undergo additional radiation therapy at week 13.

REGIMEN D:

INDUCTION PHASE: Patients undergo radiation therapy on weeks 1-7.

SURGERY: Patients undergo surgery on week 10.

CONTINUATION PHASE: If applicable, patients undergo additional radiation therapy at week 13.

After completion of study treatment, patients are followed up at 6, 12, 18, 24, 30, 36, 48, and 60 months.

Condition or Disease

Intervention/Treatment

Alveolar Soft Part Sarcoma Angiomatoid Fibrous Histiocytoma Atypical Fibroxanthoma Clear Cell Sarcoma of Soft Tissue Epithelioid Malignant Peripheral Nerve Sheath Tumor Epithelioid Sarcoma Extraskeletal Myxoid Chondrosarcoma Extraskeletal Osteosarcoma Fibrohistiocytic Neoplasm Fibrosarcoma Inflammatory Myofibroblastic Tumor Intimal Sarcoma Leiomyosarcoma Liposarcoma Liver Embryonal Sarcoma Low Grade Fibromyxoid Sarcoma Low Grade Myofibroblastic Sarcoma Malignant Peripheral Nerve Sheath Tumor Malignant Skin Granular Cell Tumor Malignant Triton Tumor Mesenchymal Chondrosarcoma Myxofibrosarcoma Myxoid Chondrosarcoma Myxoinflammatory Fibroblastic Sarcoma Nerve Sheath Neoplasm PEComa Pericytic Neoplasm Plexiform Fibrohistiocytic Tumor Sclerosing Epithelioid Fibrosarcoma Skin Glomus Tumor Stage IB Soft Tissue Sarcoma AJCC v7 Stage IIB Soft Tissue Sarcoma AJCC v7 Stage III Soft Tissue Sarcoma AJCC v7 Stage IV Soft Tissue Sarcoma AJCC v7 Synovial Sarcoma Undifferentiated High Grade Pleomorphic Sarcoma of Bone

Drug: Doxorubicin Drug: Doxorubicin Hydrochloride Drug: Ifosfamide Drug: Pazopanib Drug: Pazopanib Hydrochloride Radiation: Radiation Therapy Procedure: Therapeutic Conventional Surgery

Study Design

Study Type	Interventional
Actual Enrollment	140 participants
Design Allocation	Randomized
Interventional Model	Parallel Assignment
Masking	None (Open Label)
Primary Purpose	Treatment
Official Title	Pazopanib Neoadjuvant Trial in Non-Rhabdomyosarcoma Soft Tissue Sarcomas (PAZNTIS): A Phase II/III Randomized Trial of Preoperative Chemoradiation or Preoperative Radiation Plus or Minus Pazopanib (NSC# 737754)
Study Start Date	July 11, 2014
Actual Primary Completion Date	June 30, 2019
Anticipated Study Completion Date	December 22, 2024

Groups and Cohorts

Group/ Cohort	Intervention/ Treatment
Regimen A (pazopanib, chemoradiation) See Regimen A Detailed Description.	Drug: Doxorubicin Given IV Drug: Doxorubicin Hydrochloride Drug: Ifosfamide Drug: Pazopanib Drug: Pazopanib Hydrochloride Radiation: Radiation Therapy Procedure: Therapeutic Conventional Surgery
Regimen B (chemoradiation) See Regimen B Detailed Description.	Drug: Doxorubicin Given IV Drug: Doxorubicin Hydrochloride Drug: Ifosfamide Radiation: Radiation Therapy Procedure: Therapeutic Conventional Surgery
Regimen C (pazopanib, radiation therapy) INDUCTION PHASE: Patients receive pazopanib PO QD on weeks 1-9. Patients undergo radiation therapy on weeks 1-7. SURGERY: Patients undergo surgery on week 10. CONTINUATION PHASE: Patients receive pazopanib PO QD on weeks 13-25. If applicable, patients undergo additional radiation therapy at week 13.	Drug: Pazopanib Drug: Pazopanib Hydrochloride Radiation: Radiation Therapy Procedure: Therapeutic Conventional Surgery
Regimen D (radiation therapy) INDUCTION PHASE: Patients undergo radiation therapy on weeks 1-7. SURGERY: Patients undergo surgery on week 10. CONTINUATION PHASE: If applicable, patients undergo additional radiation therapy at week 13.	Radiation: Radiation Therapy Procedure: Therapeutic Conventional Surgery

Outcome Measures

Primary Outcome Measures

1. Feasible Dose: Pediatric [After the first 6 weeks of Induction]
   The dose of pazopanib that is feasible when given in combination with radiation or chemoradiation in pediatric unresected intermediate- and high-risk NRSTS patients. Initially, up to 10 patients (minimum of 3 patients ≥ 2 and < 18 years of age and 3 patients ≥ 18 years of age) eligible for each of the two study cohorts were non-randomly assigned (to generate 8 patients evaluable for toxicity) to receive treatment with pazopanib at dose level 1. A protocol-defined list of pazopanib-associated adverse events were defined as dose-limiting toxicities. The pazopanib dose determined to be feasible was based on the number of patient-reported dose-limiting toxicities encountered.
2. Feasible Dose: Adult [After the first 6 weeks of Induction]
   The dose of pazopanib that is feasible when given in combination with radiation or chemoradiation in adult unresected intermediate- and high-risk NRSTS patients. Initially, up to 10 patients (minimum of 3 patients ≥ 2 and < 18 years of age and 3 patients ≥ 18 years of age) eligible for each of the two study cohorts were non-randomly assigned (to generate 8 patients evaluable for toxicity) to receive treatment with pazopanib at dose level 1. A protocol-defined list of pazopanib-associated adverse events were defined as dose-limiting toxicities. The pazopanib dose determined to be feasible was based on the number of patient-reported dose-limiting toxicities encountered.
3. Percentage of Chemoradiotherapy Patients With Positive Pathologic Response at Week 13 [Week 13 after induction]
   A responder is defined by more than (90% tumor necrosis at week 13). A non-responder has less than 90% necrosis or progressive disease before week 13.
4. Percentage of Radiotherapy Patients With Positive Pathologic Response at Week 10 [Week 10 after induction]
   A responder is defined by more than 90% tumor necrosis at week 10. A non-responder has less than 90% necrosis or progressive disease before week 10.
5. Percentage of Radiotherapy Patients Failure Free at 5 Years Following Study Entry [From enrollment to up to 60 months]
   Time to the first occurrence of relapse, progression, secondary cancer or death from any cause.

Secondary Outcome Measures

1. Percentage of Patients Local Failure Free at 5 Years Following Study Entry [From enrollment to up to 60 months]
   Defined as disease recurrence only at the primary site of disease at diagnosis. The relative risk of specific failure types will be estimated and compared descriptively using the Cox proportional hazard model. Data were obtained from institutional reported data.
2. Percentage of Patients Regional Failure Free at 5 Years Following Study Entry [From enrollment to up to 60 months]
   Defined as disease recurrence at lymph nodes regional to the primary disease site, with or without local failure but without distant failure. The relative risk of specific failure types will be estimated and compared descriptively using the Cox proportional hazard model. Data were obtained from institutional reported data.
3. Percentage of Patients Distant Failure Free at 5 Years Following Study Entry [From enrollment to up to 60 months]
   Defined as disease recurrence at sites other than the primary site and diagnosis and nodes regional to that site (metastatic disease, whether or not present at diagnosis), with or without loco-regional failure. The relative risk of specific failure types will be estimated and compared descriptively using the Cox proportional hazard model. Data were obtained from institutional reported data.
4. Percentage of Patients Who Experienced Grade 3 or Higher Toxicity Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) [Reporting of adverse events was required from the start of protocol therapy and until 30 days from the last administration of study drugs; up to 1 year]
   Participants who experienced Grade 3 or higher toxicity was assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).

Eligibility Criteria

Ages Eligible for Study	2 Years and Older (Child, Adult, Older Adult)
Sexes Eligible for Study	All
Accepts Healthy Volunteers	No
Inclusion Criteria	Note: eligible patients must have a body surface area >= 0.5 m^2 AND be able to swallow whole tablets Newly diagnosed and histopathologically confirmed, potentially resectable NRSTS of the extremity and trunk will be eligible for the chemotherapy or non-chemotherapy cohort based on: Evidence of chemotherapy sensitivity of the histologic sarcoma subtype based on existing evidence from prior clinical trials Sufficient risk of metastatic disease to warrant chemotherapy based on size and grade and Medically deemed able or unable to undergo chemotherapy Notes: an incisional biopsy or core biopsy is preferred; fine needle aspiration biopsy is not acceptable to establish the diagnosis ELIGIBLE SITES: Extremities: upper (including shoulder) and lower (including hip) Trunk: body wall INELIGIBLE SITES: Head and neck, visceral organs (with the exception of embryonal sarcoma of the liver), retroperitoneum, peritoneum, pelvis within the confines of the bony pelvis ELIGIBILITY FOR CHEMOTHERAPY COHORT: Stage T2a/b (> 5 cm) and grade 2 or 3 AND One of the following chemosensitive histologies as defined in the World Health Organization (WHO) classification of soft tissue tumors (with some evidence of good response to chemoradiation and of sufficient high risk of metastases, or clear evidence of metastases): Unclassified soft tissue sarcomas that are too undifferentiated to be placed in a specific pathologic category in the WHO classification (often called "undifferentiated soft tissue sarcoma" or "soft tissue sarcoma not otherwise specified [NOS]") Synovial sarcoma Angiosarcoma of soft tissue Adult fibrosarcoma Mesenchymal (extraskeletal) chondrosarcoma Leiomyosarcoma Liposarcoma (excluding myxoid liposarcoma) Undifferentiated pleomorphic sarcoma Embryonal sarcoma of the liver Patients meeting the above criteria (histology, size, and grade) with the EXCEPTION of histologies noted above may enroll on the chemotherapy cohort or the non-chemotherapy cohort at the discretion of the enrolling investigator; patients meeting these criteria with the EXCEPTION of histologies noted above but medically deemed unable to receive chemotherapy or who elect not to receive chemotherapy are eligible for the non-chemotherapy cohort Patients with the following histologies are only eligible for the chemotherapy cohort and cannot enroll on the non-chemotherapy cohort: Unclassified soft tissue sarcomas that are too undifferentiated to be placed in a specific pathologic category in the WHO classification (often called "undifferentiated soft tissue sarcoma" or "soft tissue sarcoma NOS") in patients < 30 years of age Synovial sarcoma Embryonal sarcoma of the liver ELIGIBILITY FOR NON-CHEMOTHERAPY COHORT: Patients with any size of grade 2 or 3 of the following "intermediate (rarely metastasizing)" or "malignant" tumors, as defined in the WHO classification of soft tissue tumors for which we have consensus data of chemotherapy-resistance are eligible only for the non-chemotherapy cohort: So-called fibrohistiocytic tumors - plexiform fibrohistiocytic tumor, giant cell tumor of soft tissues Fibroblastic/myofibroblastic tumors - solitary fibrous tumor, malignant solitary fibrous tumor, inflammatory myofibroblastic tumor, low grade myofibroblastic sarcoma, myxoinflammatory fibroblastic sarcoma, atypical myxoinflammatory fibroblastic tumor, myxofibrosarcoma, low grade fibromyxoid sarcoma, sclerosing epithelioid fibrosarcoma Tumors of uncertain differentiation - epithelioid sarcoma, alveolar soft part sarcoma, clear cell sarcoma of soft tissue, angiomatoid fibrous histiocytoma, ossifying fibromyxoid tumor, myoepithelioma, myoepithelial carcinoma, extraskeletal myxoid chondrosarcoma, neoplasms with perivascular epithelioid cell differentiation (PEComa), intimal sarcoma, atypical fibroxanthoma, mixed tumor NOS, phosphaturic mesenchymal tumor, malignant ossifying fibromyxoid tumor, malignant mixed tumor, malignant phosphaturic mesenchymal tumor Chondro-osseous tumors - extraskeletal osteosarcoma Pericytic (perivascular) tumors - malignant glomus tumor Nerve sheath tumors - malignant peripheral nerve sheath tumor, malignant granular cell tumor, epithelioid malignant peripheral nerve sheath tumor, malignant Triton tumor Undifferentiated sarcomas (with a specific pathologic category in the WHO classification) - undifferentiated round cell sarcoma, undifferentiated epithelioid sarcoma, undifferentiated spindle cell sarcoma Patients meeting the criteria (histology, size, and grade) with the EXCEPTION of histologies noted above may enroll on the non-chemotherapy cohort at the discretion of the enrolling investigator; patients meeting these criteria with the EXCEPTION of histologies noted above but medically deemed unable to receive chemotherapy or who elect not to receive chemotherapy are eligible for the non-chemotherapy cohort; note that tumors arising in bone are NOT eligible for this study Extent of disease: Patients with non-metastatic and metastatic disease are eligible Initially unresectable patients, with or without metastatic disease, are eligible as long as there is a commitment at enrollment to resect the primary tumor Sufficient tissue and blood must be available to submit for required biology studies Lansky performance status score >= 70 for patients =< 16 years of age Karnofsky performance status score >= 70 for patients > 16 years of age Absolute neutrophil count >= 1500/uL; Note: no transfusions are permitted 7 days prior to laboratory studies to determine eligibility Platelet count >= 100,000/uL; Note: no transfusions are permitted 7 days prior to laboratory studies to determine eligibility Hemoglobin >= 8 g/dL for patients =< 16 years of age; >= 9 g/dL for patients > 16 years of age; Note: no transfusions are permitted 7 days prior to laboratory studies to determine eligibility Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or normal serum creatinine based on age/gender as follows: 2 to < 6 years; 0.8 mg/dL male; 0.8 mg/dL female 6 to < 10 years; 1 mg/dL male; 1 mg/dL female 10 to < 13 years; 1.2 mg/dL male; 1.2 mg/dL female 13 to < 16 years; 1.5 mg/dL male; 1.4 mg/dL female >= 16 years; 1.5 mg/dL male; 1.4 mg/dL female Total bilirubin =< 1.5 x upper limit of normal (ULN) for age Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x upper limit of normal (ULN) for age Shortening fraction of >= 27% by echocardiogram OR ejection fraction of >= 50% by radionuclide angiogram Corrected QT interval (QTc) < 480 msec No evidence of dyspnea at rest, no exercise intolerance, and a resting pulse oximetry reading > 94% on room air if there is clinical indication for determination Patients on low molecular weight heparin or Coumadin (with a stable international normalized ratio [INR]) are eligible Patient must have a life expectancy of at least 3 months with appropriate therapy All patients and/or their parents or legal guardians must sign a written informed consent All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria	Patients with grade 1 NRSTS tumors of any size are not eligible Patients with known central nervous system (CNS) metastases are not eligible; Note: brain imaging is not an eligibility requirement Patients with evidence of active bleeding or bleeding diathesis will be excluded (Note: patients aged > 17 years with excess of 2.5 mL of hemoptysis are not eligible) Patients with gross total resection of the primary tumor prior to enrollment on ARST1321 are NOT eligible; patients who have experienced tumor recurrence after a gross total tumor resection are NOT eligible Patients with uncontrolled hypertension are ineligible; uncontrolled hypertension is defined as follows: Patients aged =< 17 years: greater than 95th percentile systolic and diastolic blood pressure based on age and height which is not controlled by one anti-hypertensive medication Patients aged > 17 years: systolic blood pressure >= 140 mmHg and/or diastolic blood pressure >= 90 mmHg that is not controlled by one anti-hypertensive medication Prior Therapy: Patients must have had no prior anthracycline (e.g., doxorubicin, daunorubicin) or ifosfamide chemotherapy Patients must have had no prior use of pazopanib or similar multi-targeted tyrosine kinase inhibitors (TKI) Patients must have had no prior radiotherapy to tumor-involved sites Note: patients previously treated for a non-NRSTS cancer are eligible provided they meet the prior therapy requirements; patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier are excluded Other types of invasive malignancy that are not disease free within 3 years except for non-melanoma skin cancer, lentigo maligna, any carcinoma-in-situ or prostate cancer with low risk factors CYTOCHROME P450 3A4 (CYP3A4) substrates WITH narrow therapeutic indices: patients chronically receiving medications known to be metabolized by CYP3A4 and with narrow therapeutic indices within 7 days prior to study enrollment, including but not limited to pimozide, aripiprazole, triazolam, ergotamine and halofantrine are not eligible; Note: the use of fentanyl is permitted CYP3A4 Inhibitors: patients chronically receiving drugs that are known potent CYP3A4 inhibitors within 7 days prior to study enrollment, including but not limited to itraconazole, clarithromycin, erythromycin many non-nucleoside reverse-transcriptase inhibitors (NNRTIs), diltiazem, verapamil, and grapefruit juice are not eligible CYP3A4 Inducers: patients chronically receiving drugs that are known potent CYP3A4 inducers within 14 days prior to study enrollment, including but not limited to carbamazepine, phenobarbital, phenytoin, rifampin, and St. John's wort are not eligible (with the exception of glucocorticoids) Certain medications that are associated with a risk for QTc prolongation and/or Torsades de Pointes, although not prohibited, should be avoided or replaced with medications that do not carry these risks, if possible Subjects with any condition that may impair the ability to swallow or absorb oral medications/investigational product including: Any lesion, whether induced by tumor, radiation or other conditions, which makes it difficult to swallow capsules or pills Prior surgical procedures affecting absorption including, but not limited to major resection of stomach or small bowel Active peptic ulcer disease Malabsorption syndrome Subjects with any condition that may increase the risk of gastrointestinal bleeding or gastrointestinal perforation, including: Active peptic ulcer disease Known intraluminal metastatic lesions Inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease) or other gastrointestinal conditions which increase the risk of perforation History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days prior to beginning study treatment Subjects with any of the following cardiovascular conditions within the past 6 months Cerebrovascular accident (CVA) or transient ischemic attack (TIA) Cardiac arrhythmia Admission for unstable angina Cardiac angioplasty or stenting Coronary artery bypass graft surgery Pulmonary embolism, untreated deep venous thrombosis (DVT) or DVT which has been treated with therapeutic anticoagulation for less than 6 weeks Arterial thrombosis Symptomatic peripheral vascular disease Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system; a subject who has a history of class II heart failure and is asymptomatic on treatment may be considered eligible History of serious or non-healing wound, ulcer, or bone fracture Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Patients who are unable to swallow whole tablets are not eligible Patients with a body surface area < 0.5 m^2 are not eligible Human immunodeficiency virus (HIV)-positive subjects on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with pazopanib; in addition, these subjects are at increased risk of lethal infections when treated with marrow-suppressive therapy Patients who are receiving any other investigational agent(s) Pregnancy and breast feeding: Female patients who are pregnant are ineligible due to risks of fetal and teratogenic adverse events as seen in animal/human studies Lactating females are not eligible unless they have agreed not to breastfeed their infants during treatment and for a period of 1 month following completion of treatment Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained Unwillingness to use an effective contraceptive method for the duration of their study participation and for at least 1 month after treatment is completed if sexually active with reproductive potential

Contacts and Locations

Sponsors and Collaborators	National Cancer Institute (NCI)
Locations	Children's Hospital of Alabama | Birmingham, Alabama, United States, 35233 University of Alabama at Birmingham Cancer Center | Birmingham, Alabama, United States, 35233 The Kirklin Clinic at Acton Road | Birmingham, Alabama, United States, 35243 Anchorage Associates in Radiation Medicine | Anchorage, Alaska, United States, 98508 Alaska Breast Care and Surgery LLC | Anchorage, Alaska, United States, 99508 Alaska Oncology and Hematology LLC | Anchorage, Alaska, United States, 99508 Alaska Women's Cancer Care | Anchorage, Alaska, United States, 99508 Anchorage Oncology Centre | Anchorage, Alaska, United States, 99508 Katmai Oncology Group | Anchorage, Alaska, United States, 99508 Providence Alaska Medical Center | Anchorage, Alaska, United States, 99508 Banner Children's at Desert | Mesa, Arizona, United States, 85202 Phoenix Childrens Hospital | Phoenix, Arizona, United States, 85016 Banner University Medical Center - Tucson | Tucson, Arizona, United States, 85719 Arkansas Children's Hospital | Little Rock, Arkansas, United States, 72202-3591 Kaiser Permanente-Anaheim | Anaheim, California, United States, 92806 AIS Cancer Center at San Joaquin Community Hospital | Bakersfield, California, United States, 93301 Providence Saint Joseph Medical Center/Disney Family Cancer Center | Burbank, California, United States, 91505 Kaiser Permanente Downey Medical Center | Downey, California, United States, 90242 City of Hope Comprehensive Cancer Center | Duarte, California, United States, 91010 Loma Linda University Medical Center | Loma Linda, California, United States, 92354 Miller Children's and Women's Hospital Long Beach | Long Beach, California, United States, 90806 Children's Hospital Los Angeles | Los Angeles, California, United States, 90027 Kaiser Permanente Los Angeles Medical Center | Los Angeles, California, United States, 90027 Los Angeles General Medical Center | Los Angeles, California, United States, 90033 USC / Norris Comprehensive Cancer Center | Los Angeles, California, United States, 90033 Cedars Sinai Medical Center | Los Angeles, California, United States, 90048 UCLA / Jonsson Comprehensive Cancer Center | Los Angeles, California, United States, 90095 Valley Children's Hospital | Madera, California, United States, 93636 UCSF Benioff Children's Hospital Oakland | Oakland, California, United States, 94609 Kaiser Permanente-Oakland | Oakland, California, United States, 94611 Children's Hospital of Orange County | Orange, California, United States, 92868 Lucile Packard Children's Hospital Stanford University | Palo Alto, California, United States, 94304 Stanford Cancer Institute Palo Alto | Palo Alto, California, United States, 94304 Kaiser Permanente-Riverside | Riverside, California, United States, 92505 Sutter Medical Center Sacramento | Sacramento, California, United States, 95816 University of California Davis Comprehensive Cancer Center | Sacramento, California, United States, 95817 Kaiser Permanente-San Diego Zion | San Diego, California, United States, 92120 Rady Children's Hospital - San Diego | San Diego, California, United States, 92123 UCSF Medical Center-Mission Bay | San Francisco, California, United States, 94158 Kaiser Permanente-San Marcos | San Marcos, California, United States, 92078 Kaiser San Rafael-Gallinas | San Rafael, California, United States, 94903 Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Torrance, California, United States, 90502 Gene Upshaw Memorial Tahoe Forest Cancer Center | Truckee, California, United States, 96161 Children's Hospital Colorado | Aurora, Colorado, United States, 80045 UCHealth University of Colorado Hospital | Aurora, Colorado, United States, 80045 UCHealth Memorial Hospital Central | Colorado Springs, Colorado, United States, 80909 Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center | Denver, Colorado, United States, 80218 Poudre Valley Hospital | Fort Collins, Colorado, United States, 80524 Connecticut Children's Medical Center | Hartford, Connecticut, United States, 06106 Yale University | New Haven, Connecticut, United States, 06520 Alfred I duPont Hospital for Children | Wilmington, Delaware, United States, 19803 MedStar Georgetown University Hospital | Washington, District of Columbia, United States, 20007 Children's National Medical Center | Washington, District of Columbia, United States, 20010 UM Sylvester Comprehensive Cancer Center at Deerfield Beach | Deerfield Beach, Florida, United States, 33442 Golisano Children's Hospital of Southwest Florida | Fort Myers, Florida, United States, 33908 University of Florida Health Science Center - Gainesville | Gainesville, Florida, United States, 32610 Memorial Regional Hospital/Joe DiMaggio Children's Hospital | Hollywood, Florida, United States, 33021 Nemours Children's Clinic-Jacksonville | Jacksonville, Florida, United States, 32207 University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami, Florida, United States, 33136 Nicklaus Children's Hospital | Miami, Florida, United States, 33155 AdventHealth Orlando | Orlando, Florida, United States, 32803 Nemours Children's Hospital | Orlando, Florida, United States, 32827 Nemours Children's Clinic - Pensacola | Pensacola, Florida, United States, 32504 Johns Hopkins All Children's Hospital | Saint Petersburg, Florida, United States, 33701 Saint Joseph's Hospital/Children's Hospital-Tampa | Tampa, Florida, United States, 33607 Moffitt Cancer Center | Tampa, Florida, United States, 33612 Saint Mary's Hospital | West Palm Beach, Florida, United States, 33407 Emory University Hospital Midtown | Atlanta, Georgia, United States, 30308 Emory University Hospital/Winship Cancer Institute | Atlanta, Georgia, United States, 30322 Children's Healthcare of Atlanta - Arthur M Blank Hospital | Atlanta, Georgia, United States, 30329 Augusta University Medical Center | Augusta, Georgia, United States, 30912 Memorial Health University Medical Center | Savannah, Georgia, United States, 31404 Straub Clinic and Hospital | Honolulu, Hawaii, United States, 96813 Kaiser Permanente Moanalua Medical Center | Honolulu, Hawaii, United States, 96819 Kapiolani Medical Center for Women and Children | Honolulu, Hawaii, United States, 96826 Saint Luke's Cancer Institute - Boise | Boise, Idaho, United States, 83712 Saint Luke's Cancer Institute - Fruitland | Fruitland, Idaho, United States, 83619 Saint Luke's Cancer Institute - Meridian | Meridian, Idaho, United States, 83642 Saint Luke's Cancer Institute - Nampa | Nampa, Idaho, United States, 83687 Saint Luke's Cancer Institute - Twin Falls | Twin Falls, Idaho, United States, 83301 Lurie Children's Hospital-Chicago | Chicago, Illinois, United States, 60611 Northwestern University | Chicago, Illinois, United States, 60611 Rush University Medical Center | Chicago, Illinois, United States, 60612 University of Illinois | Chicago, Illinois, United States, 60612 University of Chicago Comprehensive Cancer Center | Chicago, Illinois, United States, 60637 Northwestern Medicine Cancer Center Delnor | Geneva, Illinois, United States, 60134 Loyola University Medical Center | Maywood, Illinois, United States, 60153 Good Samaritan Regional Health Center | Mount Vernon, Illinois, United States, 62864 UC Comprehensive Cancer Center at Silver Cross | New Lenox, Illinois, United States, 60451 Advocate Children's Hospital-Oak Lawn | Oak Lawn, Illinois, United States, 60453 Advocate Children's Hospital-Park Ridge | Park Ridge, Illinois, United States, 60068 Saint Jude Midwest Affiliate | Peoria, Illinois, United States, 61637 Saint John's Hospital | Springfield, Illinois, United States, 62702 Southern Illinois University School of Medicine | Springfield, Illinois, United States, 62702 Springfield Memorial Hospital | Springfield, Illinois, United States, 62781 Northwestern Medicine Cancer Center Warrenville | Warrenville, Illinois, United States, 60555 Riley Hospital for Children | Indianapolis, Indiana, United States, 46202 Ascension Saint Vincent Indianapolis Hospital | Indianapolis, Indiana, United States, 46260 Reid Health | Richmond, Indiana, United States, 47374 Blank Children's Hospital | Des Moines, Iowa, United States, 50309 Iowa Methodist Medical Center | Des Moines, Iowa, United States, 50309 Mission Cancer and Blood - Des Moines | Des Moines, Iowa, United States, 50309 Broadlawns Medical Center | Des Moines, Iowa, United States, 50314 Iowa Lutheran Hospital | Des Moines, Iowa, United States, 50316 University of Iowa/Holden Comprehensive Cancer Center | Iowa City, Iowa, United States, 52242 Siouxland Regional Cancer Center | Sioux City, Iowa, United States, 51101 Methodist West Hospital | West Des Moines, Iowa, United States, 50266-7700 Newman Regional Health | Emporia, Kansas, United States, 66801 Central Care Cancer Center - Garden City | Garden City, Kansas, United States, 67846 Saint Catherine Hospital | Garden City, Kansas, United States, 67846 Central Care Cancer Center - Great Bend | Great Bend, Kansas, United States, 67530 Saint Rose Ambulatory and Surgery Center | Great Bend, Kansas, United States, 67530 HaysMed | Hays, Kansas, United States, 67601 University of Kansas Cancer Center | Kansas City, Kansas, United States, 66160 Olathe Health Cancer Center | Olathe, Kansas, United States, 66061 University of Kansas Cancer Center-Overland Park | Overland Park, Kansas, United States, 66210 Ascension Via Christi - Pittsburg | Pittsburg, Kansas, United States, 66762 Salina Regional Health Center | Salina, Kansas, United States, 67401 University of Kansas Health System Saint Francis Campus | Topeka, Kansas, United States, 66606 University of Kansas Hospital-Westwood Cancer Center | Westwood, Kansas, United States, 66205 University of Kentucky/Markey Cancer Center | Lexington, Kentucky, United States, 40536 Norton Children's Hospital | Louisville, Kentucky, United States, 40202 Norton Hospital Pavilion and Medical Campus | Louisville, Kentucky, United States, 40202 Norton Suburban Hospital and Medical Campus | Louisville, Kentucky, United States, 40207 Children's Hospital New Orleans | New Orleans, Louisiana, United States, 70118 Ochsner Medical Center Jefferson | New Orleans, Louisiana, United States, 70121 Eastern Maine Medical Center | Bangor, Maine, United States, 04401 Maine Children's Cancer Program | Scarborough, Maine, United States, 04074 Sinai Hospital of Baltimore | Baltimore, Maryland, United States, 21215 Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore, Maryland, United States, 21287 Walter Reed National Military Medical Center | Bethesda, Maryland, United States, 20889-5600 Massachusetts General Hospital Cancer Center | Boston, Massachusetts, United States, 02114 Dana-Farber Cancer Institute | Boston, Massachusetts, United States, 02215 UMass Memorial Medical Center - University Campus | Worcester, Massachusetts, United States, 01655 C S Mott Children's Hospital | Ann Arbor, Michigan, United States, 48109 Bronson Battle Creek | Battle Creek, Michigan, United States, 49017 Henry Ford Cancer Institute-Downriver | Brownstown, Michigan, United States, 48183 Henry Ford Macomb Hospital-Clinton Township | Clinton Township, Michigan, United States, 48038 Wayne State University/Karmanos Cancer Institute | Detroit, Michigan, United States, 48201 Henry Ford Hospital | Detroit, Michigan, United States, 48202 Henry Ford Health Saint John Hospital | Detroit, Michigan, United States, 48236 Michigan State University Clinical Center | East Lansing, Michigan, United States, 48824 Hurley Medical Center | Flint, Michigan, United States, 48503 Corewell Health Grand Rapids Hospitals - Butterworth Hospital | Grand Rapids, Michigan, United States, 49503 Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital | Grand Rapids, Michigan, United States, 49503 Trinity Health Grand Rapids Hospital | Grand Rapids, Michigan, United States, 49503 Allegiance Health | Jackson, Michigan, United States, 49201 Bronson Methodist Hospital | Kalamazoo, Michigan, United States, 49007 West Michigan Cancer Center | Kalamazoo, Michigan, United States, 49007 Ascension Borgess Hospital | Kalamazoo, Michigan, United States, 49048 University of Michigan Health - Sparrow Lansing | Lansing, Michigan, United States, 48912 Trinity Health Muskegon Hospital | Muskegon, Michigan, United States, 49444 Corewell Health Lakeland Hospitals - Niles Hospital | Niles, Michigan, United States, 49120 Corewell Health Reed City Hospital | Reed City, Michigan, United States, 49677 Corewell Health Children's | Royal Oak, Michigan, United States, 48073 Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center | Saint Joseph, Michigan, United States, 49085 Corewell Health Lakeland Hospitals - Saint Joseph Hospital | Saint Joseph, Michigan, United States, 49085 Munson Medical Center | Traverse City, Michigan, United States, 49684 Henry Ford West Bloomfield Hospital | West Bloomfield, Michigan, United States, 48322 Essentia Health Cancer Center | Duluth, Minnesota, United States, 55805 Children's Hospitals and Clinics of Minnesota - Minneapolis | Minneapolis, Minnesota, United States, 55404 University of Minnesota/Masonic Cancer Center | Minneapolis, Minnesota, United States, 55455 Mayo Clinic in Rochester | Rochester, Minnesota, United States, 55905 University of Mississippi Medical Center | Jackson, Mississippi, United States, 39216 Central Care Cancer Center - Bolivar | Bolivar, Missouri, United States, 65613 University of Missouri Children's Hospital | Columbia, Missouri, United States, 65212 Siteman Cancer Center at West County Hospital | Creve Coeur, Missouri, United States, 63141 Freeman Health System | Joplin, Missouri, United States, 64804 Children's Mercy Hospitals and Clinics | Kansas City, Missouri, United States, 64108 The University of Kansas Cancer Center-South | Kansas City, Missouri, United States, 64131 Research Medical Center | Kansas City, Missouri, United States, 64132 University of Kansas Cancer Center - North | Kansas City, Missouri, United States, 64154 University of Kansas Cancer Center - Lee's Summit | Lee's Summit, Missouri, United States, 64064 Delbert Day Cancer Institute at PCRMC | Rolla, Missouri, United States, 65401 Mercy Clinic-Rolla-Cancer and Hematology | Rolla, Missouri, United States, 65401 Cardinal Glennon Children's Medical Center | Saint Louis, Missouri, United States, 63104 Washington University School of Medicine | Saint Louis, Missouri, United States, 63110 Mercy Hospital Saint Louis | Saint Louis, Missouri, United States, 63141 Mercy Hospital Springfield | Springfield, Missouri, United States, 65804 CoxHealth South Hospital | Springfield, Missouri, United States, 65807 Children's Hospital and Medical Center of Omaha | Omaha, Nebraska, United States, 68114 University of Nebraska Medical Center | Omaha, Nebraska, United States, 68198 Radiation Oncology Centers of Nevada Central | Las Vegas, Nevada, United States, 89106 GenesisCare USA - Las Vegas | Las Vegas, Nevada, United States, 89109 Alliance for Childhood Diseases/Cure 4 the Kids Foundation | Las Vegas, Nevada, United States, 89135 Summerlin Hospital Medical Center | Las Vegas, Nevada, United States, 89144 Comprehensive Cancer Centers of Nevada | Las Vegas, Nevada, United States, 89148 Renown Regional Medical Center | Reno, Nevada, United States, 89502 Saint Mary's Regional Medical Center | Reno, Nevada, United States, 89503 Radiation Oncology Associates | Reno, Nevada, United States, 89509 Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center | Lebanon, New Hampshire, United States, 03756 Hackensack University Medical Center | Hackensack, New Jersey, United States, 07601 Morristown Medical Center | Morristown, New Jersey, United States, 07960 Saint Peter's University Hospital | New Brunswick, New Jersey, United States, 08901 Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital | New Brunswick, New Jersey, United States, 08903 Newark Beth Israel Medical Center | Newark, New Jersey, United States, 07112 Saint Joseph's Regional Medical Center | Paterson, New Jersey, United States, 07503 University of New Mexico Cancer Center | Albuquerque, New Mexico, United States, 87106 Albany Medical Center | Albany, New York, United States, 12208 Montefiore Medical Center-Einstein Campus | Bronx, New York, United States, 10461 Montefiore Medical Center-Weiler Hospital | Bronx, New York, United States, 10461 Montefiore Medical Center - Moses Campus | Bronx, New York, United States, 10467 Roswell Park Cancer Institute | Buffalo, New York, United States, 14263 Glens Falls Hospital | Glens Falls, New York, United States, 12801 NYU Langone Hospital - Long Island | Mineola, New York, United States, 11501 The Steven and Alexandra Cohen Children's Medical Center of New York | New Hyde Park, New York, United States, 11040 Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York, New York, United States, 10016 Mount Sinai Hospital | New York, New York, United States, 10029 NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York, New York, United States, 10032 NYP/Weill Cornell Medical Center | New York, New York, United States, 10065 University of Rochester | Rochester, New York, United States, 14642 State University of New York Upstate Medical University | Syracuse, New York, United States, 13210 New York Medical College | Valhalla, New York, United States, 10595 Mission Hospital | Asheville, North Carolina, United States, 28801 UNC Lineberger Comprehensive Cancer Center | Chapel Hill, North Carolina, United States, 27599 Carolinas Medical Center/Levine Cancer Institute | Charlotte, North Carolina, United States, 28203 Novant Health Presbyterian Medical Center | Charlotte, North Carolina, United States, 28204 Duke University Medical Center | Durham, North Carolina, United States, 27710 East Carolina University | Greenville, North Carolina, United States, 27834 Matthews Radiation Oncology Center | Matthews, North Carolina, United States, 28105 Wake Forest University Health Sciences | Winston-Salem, North Carolina, United States, 27157 Sanford Broadway Medical Center | Fargo, North Dakota, United States, 58122 Children's Hospital Medical Center of Akron | Akron, Ohio, United States, 44308 UHHS-Chagrin Highlands Medical Center | Beachwood, Ohio, United States, 44122 Indu and Raj Soin Medical Center | Beavercreek, Ohio, United States, 45431 Dayton Physicians LLC-Miami Valley South | Centerville, Ohio, United States, 45459 Miami Valley Hospital South | Centerville, Ohio, United States, 45459 Cincinnati Children's Hospital Medical Center | Cincinnati, Ohio, United States, 45229 Oncology Hematology Care Inc-Kenwood | Cincinnati, Ohio, United States, 45236 Oncology Hematology Care Inc-Blue Ash | Cincinnati, Ohio, United States, 45242 Case Western Reserve University | Cleveland, Ohio, United States, 44106 Rainbow Babies and Childrens Hospital | Cleveland, Ohio, United States, 44106 Cleveland Clinic Foundation | Cleveland, Ohio, United States, 44195 Nationwide Children's Hospital | Columbus, Ohio, United States, 43205 Ohio State University Comprehensive Cancer Center | Columbus, Ohio, United States, 43210 Dayton Children's Hospital | Dayton, Ohio, United States, 45404 Good Samaritan Hospital - Dayton | Dayton, Ohio, United States, 45406 Miami Valley Hospital | Dayton, Ohio, United States, 45409 Dayton Physician LLC - Englewood | Dayton, Ohio, United States, 45415 Miami Valley Hospital North | Dayton, Ohio, United States, 45415 Armes Family Cancer Center | Findlay, Ohio, United States, 45840 Blanchard Valley Hospital | Findlay, Ohio, United States, 45840 Orion Cancer Care | Findlay, Ohio, United States, 45840 Atrium Medical Center-Middletown Regional Hospital | Franklin, Ohio, United States, 45005-1066 Dayton Physicians LLC-Atrium | Franklin, Ohio, United States, 45005 Dayton Physicians LLC-Wayne | Greenville, Ohio, United States, 45331 Wayne Hospital | Greenville, Ohio, United States, 45331 Greater Dayton Cancer Center | Kettering, Ohio, United States, 45409 Kettering Medical Center | Kettering, Ohio, United States, 45429 Springfield Regional Cancer Center | Springfield, Ohio, United States, 45504 Springfield Regional Medical Center | Springfield, Ohio, United States, 45504 ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital | Toledo, Ohio, United States, 43606 Dayton Physicians LLC - Troy | Troy, Ohio, United States, 45373 Upper Valley Medical Center | Troy, Ohio, United States, 45373 Wright-Patterson Medical Center | Wright-Patterson Air Force Base, Ohio, United States, 45433 University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma, United States, 73104 Mercy Hospital Oklahoma City | Oklahoma City, Oklahoma, United States, 73120 Oklahoma Cancer Specialists and Research Institute-Tulsa | Tulsa, Oklahoma, United States, 74146 Saint Charles Health System | Bend, Oregon, United States, 97701 Clackamas Radiation Oncology Center | Clackamas, Oregon, United States, 97015 Bay Area Hospital | Coos Bay, Oregon, United States, 97420 Providence Portland Medical Center | Portland, Oregon, United States, 97213 Providence Saint Vincent Medical Center | Portland, Oregon, United States, 97225 Legacy Emanuel Children's Hospital | Portland, Oregon, United States, 97227 Oregon Health and Science University | Portland, Oregon, United States, 97239 Lehigh Valley Hospital-Cedar Crest | Allentown, Pennsylvania, United States, 18103 Lehigh Valley Hospital - Muhlenberg | Bethlehem, Pennsylvania, United States, 18017 Geisinger Medical Center | Danville, Pennsylvania, United States, 17822 Penn State Children's Hospital | Hershey, Pennsylvania, United States, 17033 Drexel University School of Medicine | Philadelphia, Pennsylvania, United States, 19102 Children's Hospital of Philadelphia | Philadelphia, Pennsylvania, United States, 19104 Thomas Jefferson University Hospital | Philadelphia, Pennsylvania, United States, 19107 Fox Chase Cancer Center | Philadelphia, Pennsylvania, United States, 19111 Saint Christopher's Hospital for Children | Philadelphia, Pennsylvania, United States, 19134 Allegheny General Hospital | Pittsburgh, Pennsylvania, United States, 15212 Children's Hospital of Pittsburgh of UPMC | Pittsburgh, Pennsylvania, United States, 15224 Lankenau Medical Center | Wynnewood, Pennsylvania, United States, 19096 Rhode Island Hospital | Providence, Rhode Island, United States, 02903 Prisma Health Cancer Institute - Spartanburg | Boiling Springs, South Carolina, United States, 29316 Medical University of South Carolina | Charleston, South Carolina, United States, 29425 Prisma Health Richland Hospital | Columbia, South Carolina, United States, 29203 Greenville Health System Cancer Institute-Andrews | Greenville, South Carolina, United States, 29601 Saint Francis Hospital | Greenville, South Carolina, United States, 29601 BI-LO Charities Children's Cancer Center | Greenville, South Carolina, United States, 29605 Prisma Health Cancer Institute - Butternut | Greenville, South Carolina, United States, 29605 Prisma Health Cancer Institute - Faris | Greenville, South Carolina, United States, 29605 Prisma Health Greenville Memorial Hospital | Greenville, South Carolina, United States, 29605 Saint Francis Cancer Center | Greenville, South Carolina, United States, 29607 Prisma Health Cancer Institute - Eastside | Greenville, South Carolina, United States, 29615 Prisma Health Cancer Institute - Greer | Greer, South Carolina, United States, 29650 Prisma Health Cancer Institute - Seneca | Seneca, South Carolina, United States, 29672 Sanford USD Medical Center - Sioux Falls | Sioux Falls, South Dakota, United States, 57117-5134 T C Thompson Children's Hospital | Chattanooga, Tennessee, United States, 37403 East Tennessee Childrens Hospital | Knoxville, Tennessee, United States, 37916 Saint Jude Children's Research Hospital | Memphis, Tennessee, United States, 38105 The Children's Hospital at TriStar Centennial | Nashville, Tennessee, United States, 37203 Vanderbilt University/Ingram Cancer Center | Nashville, Tennessee, United States, 37232 Dell Children's Medical Center of Central Texas | Austin, Texas, United States, 78723 Driscoll Children's Hospital | Corpus Christi, Texas, United States, 78411 Medical City Dallas Hospital | Dallas, Texas, United States, 75230 Parkland Memorial Hospital | Dallas, Texas, United States, 75235 UT Southwestern/Simmons Cancer Center-Dallas | Dallas, Texas, United States, 75390 El Paso Children's Hospital | El Paso, Texas, United States, 79905 Cook Children's Medical Center | Fort Worth, Texas, United States, 76104 Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center | Houston, Texas, United States, 77030 M D Anderson Cancer Center | Houston, Texas, United States, 77030 Covenant Children's Hospital | Lubbock, Texas, United States, 79410 UMC Cancer Center / UMC Health System | Lubbock, Texas, United States, 79415 Texas Tech University Health Sciences Center-Lubbock | Lubbock, Texas, United States, 79430 Children's Hospital of San Antonio | San Antonio, Texas, United States, 78207 Methodist Children's Hospital of South Texas | San Antonio, Texas, United States, 78229 University of Texas Health Science Center at San Antonio | San Antonio, Texas, United States, 78229 Scott and White Memorial Hospital | Temple, Texas, United States, 76508 Huntsman Cancer Institute/University of Utah | Salt Lake City, Utah, United States, 84112 Primary Children's Hospital | Salt Lake City, Utah, United States, 84113 South Jordan Health Center | South Jordan, Utah, United States, 84009 Central Vermont Medical Center/National Life Cancer Treatment | Berlin, Vermont, United States, 05602 University of Vermont Medical Center | Burlington, Vermont, United States, 05401 University of Vermont and State Agricultural College | Burlington, Vermont, United States, 05405 University of Virginia Cancer Center | Charlottesville, Virginia, United States, 22908 Inova Fairfax Hospital | Falls Church, Virginia, United States, 22042 Children's Hospital of The King's Daughters | Norfolk, Virginia, United States, 23507 Virginia Commonwealth University/Massey Cancer Center | Richmond, Virginia, United States, 23298 Carilion Children's | Roanoke, Virginia, United States, 24014 Providence Regional Cancer System-Aberdeen | Aberdeen, Washington, United States, 98520 PeaceHealth Saint Joseph Medical Center | Bellingham, Washington, United States, 98225 Providence Regional Cancer System-Centralia | Centralia, Washington, United States, 98531 Providence Regional Cancer Partnership | Everett, Washington, United States, 98201 Swedish Cancer Institute-Issaquah | Issaquah, Washington, United States, 98029 Kadlec Clinic Hematology and Oncology | Kennewick, Washington, United States, 99336 Providence Regional Cancer System-Lacey | Lacey, Washington, United States, 98503 PeaceHealth Saint John Medical Center | Longview, Washington, United States, 98632 Seattle Children's Hospital | Seattle, Washington, United States, 98105 Swedish Medical Center-Ballard Campus | Seattle, Washington, United States, 98107 Kaiser Permanente Washington | Seattle, Washington, United States, 98112 Swedish Medical Center-First Hill | Seattle, Washington, United States, 98122 Providence Sacred Heart Medical Center and Children's Hospital | Spokane, Washington, United States, 99204 Madigan Army Medical Center | Tacoma, Washington, United States, 98431 PeaceHealth Southwest Medical Center | Vancouver, Washington, United States, 98664 Providence Saint Mary Regional Cancer Center | Walla Walla, Washington, United States, 99362 North Star Lodge Cancer Center at Yakima Valley Memorial Hospital | Yakima, Washington, United States, 98902 West Virginia University Charleston Division | Charleston, West Virginia, United States, 25304 West Virginia University Healthcare | Morgantown, West Virginia, United States, 26506 Aurora Cancer Care-Southern Lakes VLCC | Burlington, Wisconsin, United States, 53105 Aurora Health Center-Fond du Lac | Fond Du Lac, Wisconsin, United States, 54937 Aurora Health Care Germantown Health Center | Germantown, Wisconsin, United States, 53022 Aurora Cancer Care-Grafton | Grafton, Wisconsin, United States, 53024 Aurora BayCare Medical Center | Green Bay, Wisconsin, United States, 54311 Aurora Cancer Care-Kenosha South | Kenosha, Wisconsin, United States, 53142 University of Wisconsin Carbone Cancer Center - University Hospital | Madison, Wisconsin, United States, 53792 Aurora Bay Area Medical Group-Marinette | Marinette, Wisconsin, United States, 54143 Marshfield Medical Center-Marshfield | Marshfield, Wisconsin, United States, 54449 Aurora Cancer Care-Milwaukee | Milwaukee, Wisconsin, United States, 53209 Aurora Saint Luke's Medical Center | Milwaukee, Wisconsin, United States, 53215 Children's Hospital of Wisconsin | Milwaukee, Wisconsin, United States, 53226 Medical College of Wisconsin | Milwaukee, Wisconsin, United States, 53226 Aurora Sinai Medical Center | Milwaukee, Wisconsin, United States, 53233 Vince Lombardi Cancer Clinic - Oshkosh | Oshkosh, Wisconsin, United States, 54904 Aurora Cancer Care-Racine | Racine, Wisconsin, United States, 53406 Vince Lombardi Cancer Clinic-Sheboygan | Sheboygan, Wisconsin, United States, 53081 Aurora Medical Center in Summit | Summit, Wisconsin, United States, 53066 Vince Lombardi Cancer Clinic-Two Rivers | Two Rivers, Wisconsin, United States, 54241 Aurora Cancer Care-Waukesha | Waukesha, Wisconsin, United States, 53188 Aurora Cancer Care-Milwaukee West | Wauwatosa, Wisconsin, United States, 53226 Aurora West Allis Medical Center | West Allis, Wisconsin, United States, 53227 Cross Cancer Institute | Edmonton, Alberta, Canada, T6G 1Z2 British Columbia Children's Hospital | Vancouver, British Columbia, Canada, V6H 3V4 CancerCare Manitoba | Winnipeg, Manitoba, Canada, R3E 0V9 Janeway Child Health Centre | Saint John's, Newfoundland and Labrador, Canada, A1B 3V6 IWK Health Centre | Halifax, Nova Scotia, Canada, B3K 6R8 McMaster Children's Hospital at Hamilton Health Sciences | Hamilton, Ontario, Canada, L8N 3Z5 Children's Hospital | London, Ontario, Canada, N6A 5W9 Hospital for Sick Children | Toronto, Ontario, Canada, M5G 1X8 CIUSSSEMTL-Hopital Maisonneuve-Rosemont | Montreal, Quebec, Canada, H1T 2M4 CHUM - Hopital Notre-Dame | Montreal, Quebec, Canada, H2L 4M1 CHUM - Centre Hospitalier de l'Universite de Montreal | Montreal, Quebec, Canada, H2X 3E4 The Montreal Children's Hospital of the MUHC | Montreal, Quebec, Canada, H3H 1P3 Centre Hospitalier Universitaire Sainte-Justine | Montreal, Quebec, Canada, H3T 1C5 Allan Blair Cancer Centre | Regina, Saskatchewan, Canada, S4T 7T1 CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) | Quebec, Canada, G1V 4G2 San Jorge Children's Hospital | San Juan, Puerto Rico, 00912 University Pediatric Hospital | San Juan, Puerto Rico, 00926
Investigators	Principal Investigator: Aaron R Weiss, Children's Oncology Group

Study Documents (Full Text)

• Documents Provided by National Cancer Institute (NCI): Study Protocol and Statistical Analysis Plan April 8, 2019

More Information

Publications

• Avutu V, Weiss AR, Reed DR, Ahmed SK, Allen-Rhoades WA, Chen YE, Davis LE, Eaton BR, Hawkins DS, Indelicato DJ, Patel SR, Randall RL, Reinke DK, Riedel RF, Scharschmidt TJ, Thornton KA, Wang D, Janeway KA, Kopp LM. Identified Enrollment Challenges of Adolescent and Young Adult Patients on the Nonchemotherapy Arm of Children's Oncology Group Study ARST1321. J Adolesc Young Adult Oncol. 2022 Jun;11(3):328-332. doi: 10.1089/jayao.2021.0103. Epub 2021 Sep 9.

• Vatner R, James CD, Sathiaseelan V, Bondra KM, Kalapurakal JA, Houghton PJ. Radiation therapy and molecular-targeted agents in preclinical testing for immunotherapy, brain tumors, and sarcomas: Opportunities and challenges. Pediatr Blood Cancer. 2021 May;68 Suppl 2:e28439. doi: 10.1002/pbc.28439. Epub 2020 Aug 22.

• Weiss AR, Chen YL, Scharschmidt TJ, Chi YY, Tian J, Black JO, Davis JL, Fanburg-Smith JC, Zambrano E, Anderson J, Arens R, Binitie O, Choy E, Davis JW, Hayes-Jordan A, Kao SC, Kayton ML, Kessel S, Lim R, Meyer WH, Million L, Okuno SH, Ostrenga A, Parisi MT, Pryma DA, Randall RL, Rosen MA, Schlapkohl M, Shulkin BL, Smith EA, Sorger JI, Terezakis S, Hawkins DS, Spunt SL, Wang D. Pathological response in children and adults with large unresected intermediate-grade or high-grade soft tissue sarcoma receiving preoperative chemoradiotherapy with or without pazopanib (ARST1321): a multicentre, randomised, open-label, phase 2 trial. Lancet Oncol. 2020 Aug;21(8):1110-1122. doi: 10.1016/S1470-2045(20)30325-9. Epub 2020 Jul 20.

Additional Relevant MeSH Terms

• Neoplasms
• Sarcoma
• Osteosarcoma
• Leiomyosarcoma
• Liposarcoma
• Chondrosarcoma
• Sarcoma, Synovial
• Nerve Sheath Neoplasms
• Neurofibrosarcoma
• Fibrosarcoma
• Sarcoma, Alveolar Soft Part
• Histiocytoma
• Histiocytoma, Benign Fibrous
• Sarcoma, Clear Cell
• Chondrosarcoma, Mesenchymal
• Histiocytoma, Malignant Fibrous
• Glomus Tumor
• Granular Cell Tumor
• Neoplasms, Connective and Soft Tissue
• Neoplasms by Histologic Type
• Neoplasms, Bone Tissue
• Neoplasms, Connective Tissue
• Neoplasms, Muscle Tissue
• Neoplasms, Adipose Tissue
• Neoplasms, Nerve Tissue
• Peripheral Nervous System Neoplasms
• Nervous System Neoplasms
• Nervous System Diseases
• Peripheral Nervous System Diseases
• Neuromuscular Diseases
• Neoplasms, Fibrous Tissue
• Neurofibroma
• Neoplasms, Vascular Tissue