A Randomized Phase III Study of Neoadjuvant Chemotherapy Followed by Surgery Versus Surgery Alone for Patients With High Risk RetroPeritoneal Sarcoma (RPS)
ClinicalTrials.gov processed this data on November 4, 2024. Link to the current ClinicalTrials.gov record.Recruitment Status
RECRUITING (See Contacts and Locations)Verified November 2024 by European Organisation for Research and Treatment of Cancer - EORTC, Canadian Cancer Trials Group, ECOG-ACRIN Cancer Research Group, Anticancer Fund, Belgium, Australia and New Zealand Sarcoma Association, Japan Clinical Oncology Group
Sponsor
European Organisation for Research and Treatment of Cancer - EORTCInformation Provided by (Responsible Party)
European Organisation for Research and Treatment of Cancer - EORTCClinicaltrials.gov Identifier
NCT04031677Other Study ID Numbers: EORTC 1809-STBSG
First Submitted: July 22, 2019
First Posted: July 24, 2019
Last Update Posted: November 5, 2024
Last Verified: November 2024
History of Changes
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Study Description
Standard arm:Large en-bloc curative-intent surgery within 4 weeks following randomization- Experimental arm
Experimental arm:
3 cycles of neoadjuvant chemotherapy starting within 2 weeks following randomization:
High grade LPS: ADM (doxorubicin) 75 mg/m2 (or the equivalent EpiADM 120 mg/m2) + ifosfamide 9 g/m3 Q3 weeks.
LMS: ADM 75 mg/m2 + DTIC (dacarbazine) 1 g/m2 Q3 weeks
re-assessment of operability
curative-intent surgery within 3-6 weeks of last cycle of chemotherapy
Condition or Disease | Intervention/Treatment |
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Study Design
Study Type | Interventional |
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Anticipated Enrollment | 250 participants |
Design Allocation | Randomized |
Interventional Model | Parallel Assignment |
Masking | None (Open Label) |
Primary Purpose | Treatment |
Official Title | A Randomized Phase III Study of Neoadjuvant Chemotherapy Followed by Surgery Versus Surgery Alone for Patients With High Risk RetroPeritoneal Sarcoma (RPS) |
Study Start Date | January 20, 2021 |
Anticipated Primary Completion Date | April 21, 2027 |
Anticipated Study Completion Date | April 21, 2028 |
Groups and Cohorts
Group/ Cohort | Intervention/ Treatment |
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Outcome Measures
Primary Outcome Measures
- Disease free survival [7 years from first patient in] Disease free survival will be measured from the date of randomization (as reference) to the date of recurrence or death, whichever occurs first.
Secondary Outcome Measures
- Overall survival (OS) [8 years from first patient in] OS will be measured from the date of randomization to the date of death, whatever the cause. Alive patients will be censored at the date of last follow-up.
- Recurrence free survival [8 years from first patient in] Recurrence free survival will be measured in patients who were successfully operated (R0/R1 resection) from the date of surgery (as reference) to the date of recurrence (local or distant) or death, whichever occurs first. Patients without one of these events will be censored at the date of last follow-up.
- Distant metastases free survival [8 years from first patient in] Distant metastases free survival will be from the date of randomization (as reference) to the date of distant metastases or death (whatever the cause), whichever occurs first. Patients without any of these events will be censored at the date of last follow-up.
- Cumulative incidence of local recurrences [8 years from first patient in] Cumulative incidence of local recurrences will be measured from the date of randomization (as reference) to the date of local recurrence.
- Cumulative incidence of distant metastases [8 years from first patient in] Cumulative incidence of distant metastases will be measured from the date of randomization to the date of occurrence of distant metastases.
- Radiological response to neoadjuvant chemotherapy according to RECIST [8 years from first patient in] For patients receiving neo-adjuvant chemotherapy, the radiological response will be assessed using RECIST 1.1 by comparison of the baseline and preoperative imaging.
- Radiological response to neoadjuvant chemotherapy according to CHOI [8 years from first patient in] For patients receiving neo-adjuvant chemotherapy, the radiological response will be also assessed using Choi criteria by comparison of the baseline and preoperative imaging.
- Pathological response [8 years from first patient in] Response evaluation will be done according to the EORTC response score.
- Safety and toxicity of neoadjuvant chemotherapy [8 years from first patient in] Safety and toxicity of neoadjuvant chemotherapy will be evaluated and graded using CTCAE V5.0.
- Perioperative complications [8 years from first patient in] Perioperative complications will be evaluated with the Dindo scale for the events related to the surgery and CTCAE V5.0 will be used for all other events.
- Late complications [8 years from first patient in] Late complications (after the 60th day following the surgery) will be evaluated and graded according to the CTCAE version 5.0.
- Health-Related Quality of life (EORTC QLQ-C30 + Item list from QLQ-STO22) [8 years from first patient in] Health-Related Quality of life assessment will be based on the EORTC QLQ C30 questionnaire version 3.0, with additional questions from the QLQ-STO22 module.
- Health utility, calculated from the collected patient-reported HRQoL data and patient demographics economics. [8 years from first patient in] he EORTC QLQ C30 data will be mapped to health utility values using an established indirect mapping approach.
Eligibility Criteria
Ages Eligible for Study | 18 Years and Older (Adult, Older Adult) |
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Sexes Eligible for Study | All |
Accepts Healthy Volunteers | No |
Inclusion Criteria |
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Exclusion Criteria |
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Contacts and Locations
Sponsors and Collaborators | European Organisation for Research and Treatment of Cancer - EORTC, Canadian Cancer Trials Group, ECOG-ACRIN Cancer Research Group, Anticancer Fund, Belgium, Australia and New Zealand Sarcoma Association, Japan Clinical Oncology Group |
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Canadian Cancer Trials Group, ECOG-ACRIN Cancer Research Group, Anticancer Fund, Belgium, Australia and New Zealand Sarcoma Association, Japan Clinical Oncology Group | |
Locations |
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More Information
Additional Relevant MeSH Terms
- Sarcoma
- Leiomyosarcoma
- Liposarcoma
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Muscle Tissue
- Neoplasms, Adipose Tissue