A Randomized Phase III Study of Neoadjuvant Chemotherapy Followed by Surgery Versus Surgery Alone for Patients with High Risk RetroPeritoneal Sarcoma (STRASS 2)
Categories (click each to see list of all clinical trials associated with that category): Sarcoma (ONC)
Current Status: Open
Phase: III (Cancer Control)
Principal Investigator: Mammen, Joshua
Contact Information:
Michaela Savine
misavine@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT04031677?term=NCT04031677&rank=1
Summary
Main objective:
The primary objective of this study is to assess whether preoperative chemotherapy, as an adjunct to curative-intent surgery, improves the prognosis of high risk DDLPS and LMS patients as measured by disease free survival.
Secondary objectives:
- To assess whether there is a difference in the overall survival, recurrence free survival, distant metastases free survival, cumulative incidence of local recurrences and cumulative incidence of distant metastases between patients undergoing curative-intent surgery alone and those undergoing preoperative chemotherapy followed by curative intent surgery
- To assess tumour response in patients undergoing preoperative chemotherapy
- To assess the toxicity profile of preoperative chemotherapy given as "neoadjuvant" treatment to curative intent surgery in patients with RPS, and of surgery alone
- To assess whether there is a difference in quality of life between patients undergoing curative-intent surgery alone and those undergoing preoperative chemotherapy followed by curative intent surgery