Surgery With or Without Radiation Therapy in Treating Patients With Previously Untreated Nonmetastatic Retroperitoneal Soft Tissue Sarcoma (STRASS)
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.
Procedure: therapeutic conventional surgery
Radiation: 3-dimensional conformal radiation therapy
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase III Randomized Study of Preoperative Radiotherapy Plus Surgery Versus Surgery Alone for Patients With Retroperitoneal Sarcoma (RPS)|
- Abdominal recurrence-free survival [ Designated as safety issue: No ]
- Acute toxicity profile of preoperative radiotherapy [ Designated as safety issue: Yes ]
- Perioperative complications [ Designated as safety issue: Yes ]
- Late complications [ Designated as safety issue: Yes ]
- Tumor response to preoperative radiotherapy [ Designated as safety issue: No ]
- Time to abdominal recurrence [ Designated as safety issue: No ]
- Metastasis-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||January 2020|
|Estimated Primary Completion Date:||January 2019 (Final data collection date for primary outcome measure)|
Active Comparator: Surgery alone
En-bloc resection of surrounding tissues and organs when located within 1 to 2 cm from the surface tumor, even when not infiltrated.
|Procedure: therapeutic conventional surgery|
Experimental: Preoperative radiotherapy followed by en-bloc surgery
3D-CRT or IMRT to a dose of 50.4 Gy/28 daily fractions
|Procedure: therapeutic conventional surgery Radiation: 3-dimensional conformal radiation therapy|
- 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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01344018
|Contact: Anne Kirkpatrick||+32 email@example.com|
|United States, Massachusetts|
|Dana-Farber Cancer Institute & Harvard Medical School||Recruiting|
|Boston, Massachusetts, United States|
|Mount Sinai Hospital||Recruiting|
|Toronto, Ontario, Canada|
|Aarhus University Hospital||Recruiting|
|Centre Leon Berard||Recruiting|
|Institut Gustave Roussy||Recruiting|
|Villejuif, France, 94805|
|Contact: Sylvie Bonvalot, Dr 0033/142114383 firstname.lastname@example.org|
|Principal Investigator: Sylvie Bonvalot, Dr|
|Fondazione IRCCS Istituto Nazionale dei Tumori||Recruiting|
|The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis||Recruiting|
|University Medical Center Groningen||Recruiting|
|Leiden University Medical Centre||Recruiting|
|University Hospitals Bristol NHS Foundation Trust - Bristol Haematology And Oncology Centre||Recruiting|
|Bristol, United Kingdom|
|Leeds Teaching Hospitals NHS Trust - St. James'S University Hospital||Recruiting|
|Leeds, United Kingdom|
|Royal Marsden Hospital - Chelsea, London||Recruiting|
|London, United Kingdom|
|Christie NHS Foundation Trust||Recruiting|
|Manchester, United Kingdom|
|Nottingham University Hospitals NHS Trust - City Hospital campus||Recruiting|
|Nottingham, United Kingdom|
|Study Chair:||Sylvie Bonvalot||Gustave Roussy, Cancer Campus, Grand Paris|
|Study Chair:||Rick LM Haas, MD||The Netherlands Cancer Institute|