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

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.

DISEASE CHARACTERISTICS:

• Histologically confirmed soft tissue sarcoma meeting the following criteria:

• Lesion originates in extremity

• Upper extremity lesions may occur from the medial border of the scapula to tumors as far distal as the finger tips

• No lesions of the chest wall arising adjacent to the scapula but not originating in the shoulder bone
• Lower extremity regions include hip girdle tumors commencing at the iliac crest, excluding lesions arising from within the pelvis, and extends to include lesions as far distal as the toes
• Imaging and pathology from first surgery are required
• Has undergone surgical resection of the tumor within the past 12 weeks

• No macroscopic tumor in situ after surgery
• Microscopically irradical surgical margin allowed
• Excisional biopsy with positive margins or other inadequate surgery (macroscopically involved margins) allowed only after further definitive re-excision
• Positive margins and no further surgery possible except amputation or major functional loss allowed provided no macroscopic residual disease is present
• Local recurrence within 3 months of prior surgery (or other treatment) allowed provided patient undergoes subsequent re-excision
• No diagnosis of any of the following:

• Rhabdomyosarcoma (alveolar or embryonal)
• Primitive neuroectodermal tumor
• Soft tissue Ewing's sarcoma
• Extraskeletal osteosarcoma
• Aggressive fibromatosis (desmoid tumors)
• Dermatofibrosarcoma protuberans
• Gorlin's syndrome
• No regional nodal disease or unequivocal distant metastasis

PATIENT CHARACTERISTICS:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3 months after completion of study treatment
• No other major medical illness that would preclude study treatment
• No other malignancy except adequately treated nonmelanomatous carcinoma of the skin or in situ carcinoma of the cervix

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No prior radiotherapy to the local site
• No prior neoadjuvant or adjuvant chemotherapy