A Phase III Randomized Study of Preoperative Radiotherapy Plus Surgery Versus Surgery Alone for Patients With Retroperitoneal Sarcoma (RPS)
- 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.
- 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
- 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
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Abdominal recurrence-free survival
Gustave Roussy, Cancer Campus, Grand Paris
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
|Dana-Farber Cancer Institute & Harvard Medical School||Boston, Massachusetts|