Surgery With or Without Radiation Therapy in Untreated Nonmetastatic Retroperitoneal Sarcoma

Official Title

A Phase III Randomized Study of Preoperative Radiation Therapy Plus Surgery Versus Surgery Alone for Patients With Retroperitoneal Sarcoma (RPS)

Summary:

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumour cells. Giving radiation therapy before surgery may make the tumour 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.

Trial Description

Primary Outcome:

  • Abdominal recurrence-free survival
Secondary Outcome:
  • Acute toxicity profile of preoperative radiation therapy
  • Perioperative complications
  • Late complications
  • Tumour response to preoperative radiation therapy
  • Time to abdominal recurrence
  • Metastasis-free survival
  • Overall survival
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 radiation therapy 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 tumour response in patients undergoing preoperative radiation therapy.
  • To assess toxicity of preoperative radiation therapy given prior to curative-intent surgery in these patients.
OUTLINE:

This is a multicentre 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 tumour 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 tumour mass within 4-8 weeks after the completion of RT. Tumour 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.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society