A Phase III Randomized Study of Preoperative Radiotherapy Plus Surgery Versus Surgery Alone for Patients With Retroperitoneal Sarcoma (RPS)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sarcoma
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC
- Enrollment
- 266
- Locations
- 37
- Primary Endpoint
- Number of Patients With Abdominal Recurrence or Death
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known whether surgery is more effective with or without radiation therapy in treating nonmetastatic retroperitoneal soft tissue sarcoma.
PURPOSE: This randomized phase III trial is studying radiation therapy followed by surgery to see how well it works compared with surgery alone in treating patients with previously untreated nonmetastatic retroperitoneal soft tissue sarcoma.
Detailed Description
OBJECTIVES: Primary * To assess whether there is a difference in abdominal recurrence-free survival between retroperitoneal soft tissue sarcoma patients undergoing curative intent surgery alone and those undergoing preoperative radiotherapy followed by curative-intent surgery. Secondary * To assess whether there is a difference in metastasis-free survival, abdominal recurrence-free interval, and overall survival between these patients. * To assess tumor response in patients undergoing preoperative radiotherapy. * To assess toxicity of preoperative radiotherapy given prior to curative-intent surgery in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to institution and WHO performance status (0-1 vs 2). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients undergo surgical resection of the tumor mass within 4 weeks following randomization. * Arm II: Patients undergo 3-dimensional conformal radiation therapy (RT) or intensity-modulated RT within 8 weeks after randomization. RT continues 5 days a week for approximately 5.5 weeks. Patients undergo surgical resection of the tumor mass within 4-8 weeks after the completion of RT. Tumor tissue, normal abdominal wall fat, and peripheral blood may be collected during surgery to identify new prognostic factors for translational research. After completion of study therapy, patients are followed at day 60 post-surgery and every 6 months thereafter.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of Patients With Abdominal Recurrence or Death
Time Frame: ARFS was measured from date of randomization to date of abdominal relapse or death, whichever occurred first, up to a maximum of 7 years.
Abdominal recurrence was defined by one of the following events: local/abdominal or distant progressive disease during preoperative radiotherapy (as per RECIST 1.1), tumor or patient becoming inoperable (ASA score of 3 or involvement of superior mesenteric artery, aorta, or bone), peritoneal metastasis found at surgery, macroscopic residual disease left in at surgery (R2 resection), or local relapse (after macroscopically complete resection). Liver metastases were regarded as distant metastatic events. Patients with distant metastases were followed until local failure was detected. Patients without one of these events were censored at the date of last follow-up.
Secondary Outcomes
- Acute Toxicity Profile of Preoperative Radiotherapy.(From date of randomization to the date of surgical procedure, prior to surgery)
- Perioperative Complications(From the date of surgery, up to 60 days following surgery)
- Late Complications(From day 60 after surgery till end of follow-up, up to 7 years)
- Tumor Response to Preoperative Radiotherapy(Two weeks after completion of Pre-operative Radiotherapy, before Surgery)
- Number of Patients With an Abdominal Recurrence(ARFI was measured from the date of randomization to the date of abdominal relapse, up to a maximum of 7 years)
- Number of Patients With Metastases or Death(Metastases free survival was measured from the date of randomization to the date of occurrence of distant metastases or death, whichever occurred first, up to a maximum of 7 years.)
- Number of Patients Alive(Overall survival was measured from the date of randomization to the date of death, whatever the cause, up to a maximum of 7 years)