Patient case: 78-year-old female with sarcoma; genetic feature: MDM2

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

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.

Eligibility: 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

Relevance to patient case: not relevant