Radiation Therapy in Treating Patients Who Have Undergone Surgery for Soft Tissue Sarcoma of the Arms, Hands, Legs, or Feet
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether giving radiation therapy to a smaller area of tissue surrounding the tumor is as effective as giving radiation therapy to a wider area of tissue surrounding the tumor in treating soft tissue sarcoma.
PURPOSE: This randomized phase III trial is studying giving external-beam radiation therapy to a small area of tissue surrounding the tumor to see how well it works compared with giving external-beam radiation therapy to a wider area of tissue surrounding the tumor in treating patients who have undergone surgery for soft tissue sarcoma of the arms, hands, legs, or feet.
Procedure: adjuvant therapy
Radiation: radiation therapy
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||Randomised Trial of Post-Operative Radiotherapy Given to Adult Patients With Extremity Soft Tissue Sarcoma [VORTEX]|
- Limb functionality as measured by the Toronto Extremity Salvage Score (TESS) [ Designated as safety issue: No ]
- Time to local recurrence [ Designated as safety issue: No ]
- Soft tissue and bone toxicity as measured by RTOG [ Designated as safety issue: Yes ]
- Disease-free survival [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Overall level of disability as measured by the TESS questionnaire [ Designated as safety issue: No ]
|Study Start Date:||March 2006|
|Study Completion Date:||July 2011|
- Determine if reduced volume adjuvant radiotherapy increases limb function without compromising local control in patients with previously resected extremity soft tissue sarcoma.
- Determine the toxicity of this regimen in these patients.
- Determine the overall level of disability in patients treated with this regimen.
- Determine the disease-free survival and overall survival of these patients.
OUTLINE: This is a randomized, controlled, prospective, multicenter study. Patients are stratified according to tumor grade (1 vs 2 vs 3), adequacy of surgical clearance (R0 vs R1), and treatment center. Patients are randomized to 1 of 2 treatment arms.
- Arm I (control): Patients undergo external beam radiotherapy (EBRT), including full margins, once daily 5 days a week for 6½ weeks .
- Arm II: Patients undergo EBRT as in arm I but only reduced margins are included.
After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00423618
|Royal Orthopedic Hospital NHS Trust|
|Birmingham, England, United Kingdom, B31 2AP|
|Manchester, England, United Kingdom, M20 4BX|
|Mount Vernon Cancer Centre at Mount Vernon Hospital|
|Northwood, England, United Kingdom, HA6 2RN|
|Nottingham City Hospital|
|Nottingham, England, United Kingdom, NG5 1PB|
|Cancer Research Centre at Weston Park Hospital|
|Sheffield, England, United Kingdom, S1O 2SJ|
|North Glasgow University Hospitals NHS Trust|
|Glasgow, United Kingdom, G21 3UR|
|Study Chair:||Martin Robinson, MD||Cancer Research Centre at Weston Park Hospital|