Randomised Trial of Volume of Post-operative Radiotherapy Given to Adult Patients With eXtremity Soft Tissue Sarcoma
- Conditions
- Sarcoma
- Registration Number
- NCT00423618
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 216
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Time to local recurrence 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 Limb functionality as measured by the Toronto Extremity Salvage Score (TESS) 2 years
- Secondary Outcome Measures
Name Time Method Disease-free survival defined in whole days as time from randomisation into the trial to either local or distant recurrence or death (whichever occurs first). Overall level of disability as measured by the TESS questionnaire 2 years Soft tissue and bone toxicity as measured by RTOG 2 years Overall survival defined in whole days as time from randomisation into the trial to death.
Trial Locations
- Locations (6)
Royal Orthopedic Hospital NHS Trust
🇬🇧Birmingham, England, United Kingdom
Christie Hospital
🇬🇧Manchester, England, United Kingdom
Mount Vernon Cancer Centre at Mount Vernon Hospital
🇬🇧Northwood, England, United Kingdom
Nottingham City Hospital
🇬🇧Nottingham, England, United Kingdom
Cancer Research Centre at Weston Park Hospital
🇬🇧Sheffield, England, United Kingdom
North Glasgow University Hospitals NHS Trust
🇬🇧Glasgow, United Kingdom
Royal Orthopedic Hospital NHS Trust🇬🇧Birmingham, England, United Kingdom