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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
216
radiotherapy as adjuvant treatment for adults with soft tissue sarcoma extremities
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
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
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
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