Randomised Trial of Volume of Post-operative Radiotherapy Given to Adult Patients With eXtremity Soft Tissue Sarcoma
Condition: Sarcoma
MeSH terms: Sarcoma
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): radiotherapy
Intervention type(s): Radiation
Intervention description(s): radiotherapy as adjuvant treatment for adults with soft tissue sarcoma extremities
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent adult soft tissue sarcoma; stage I adult soft tissue sarcoma; stage II adult soft tissue sarcoma; stage III adult soft tissue sarcoma; adult synovial sarcoma; adult angiosarcoma; adult epithelioid sarcoma; adult extraskeletal chondrosarcoma; adult leiomyosarcoma; adult liposarcoma; adult malignant fibrous histiocytoma; adult malignant hemangiopericytoma; adult malignant mesenchymoma; adult fibrosarcoma; adult neurofibrosarcoma; adult alveolar soft-part sarcoma