NCT00423618

Randomised Trial of Volume of Post-operative Radiotherapy Given to Adult Patients With eXtremity Soft Tissue Sarcoma

Randomised Trial of Post-Operative Radiotherapy Given to Adult Patients With Extremity Soft Tissue Sarcoma [VORTEX]

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 216 (actual)
• Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 16 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: Primary * Determine if reduced volume adjuvant radiotherapy increases limb function without compromising local control in patients with previously resected extremity soft tissue sarcoma. Secondary * 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.

Conditions

• Sarcoma

Interventions

Type	Name	Description
RADIATION	radiotherapy	radiotherapy as adjuvant treatment for adults with soft tissue sarcoma extremities

Timeline

• Start date: 2006-03-01
• Primary completion: 2018-12-31
• Completion: 2018-12-31
• First posted: 2007-01-18
• Last updated: 2021-03-18

Locations

6 sites across 1 country: United Kingdom