Clinical Trial: Randomised Trial of Volume of Post-operative Radiotherapy Given to Adult Patients With eXtremity Soft Tissue Sarcoma
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Randomised Trial of Post-Operative Radiotherapy Given to Adult Patients With Extremity Soft Tissue Sarcoma [VORTEX]
Brief 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 Summary:
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.
Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Current Primary Outcome:
- Limb functionality as measured by the Toronto Extremity Salvage Score (TESS) [ Time Frame: 2 years ]
- Time to local recurrence [ Time Frame: time from randomisation into the trial to the occasion when a local recurrence is confirmed by biopsy. For those patients who are not observed to have a local recurrence during the course of the study, the time to local recu ]
Original Primary Outcome:
- Limb functionality as measured by the Toronto Extremity Salvage Score (TESS)
- Time to local recurrence
Current Secondary Outcome:
- Soft tissue and bone toxicity as measured by RTOG [ Time Frame: 2 years ]
- Disease-free survival [ Time Frame: defined in whole days as time from randomisation into the trial to either local or distant recurrence or death (whichever occurs first). ]
- Overall survival [ Time Frame: defined in whole days as time from randomisation into the trial to death. ]
- Overall level of disability as measured by the TESS questionnaire [ Time Frame: 2 years ]
Original Secondary Outcome:
- Soft tissue and bone toxicity as measured by RTOG
- Disease-free survival
- Overall survival
- Overall level of disability as measured by the TESS questionnaire
Information By: Sheffield Teaching Hospitals NHS Foundation Trust
Dates:
Date Received: January 17, 2007
Date Started: March 2006
Date Completion: December 2018
Last Updated: January 19, 2017
Last Verified: January 2017