Randomised Trial of Post-Operative Radiotherapy Given to Adult Patients With Extremity Soft Tissue Sarcoma [VORTEX]
- Determine if reduced volume adjuvant radiotherapy increases limb function without
compromising local control in patients with previously resected extremity soft tissue
- 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.
Allocation: Randomized, Primary Purpose: Treatment
Limb functionality as measured by the Toronto Extremity Salvage Score (TESS)
Martin Robinson, MD
Cancer Research Centre at Weston Park Hospital