The Treatment of Grade I Sarcomas and Benign, Non-Metastasizing Highly Invasive Soft Tissue Tumors

Launched by NATIONAL CANCER INSTITUTE (NCI) · Dec 9, 2002

Keywords

ClinConnect Summary

This is a randomized study. Patients undergo surgical excision of all gross disease and then are randomized to Arm I or Arm II.

Arm I: Radiotherapy. Involved-field irradiation.

Arm II: No further treatment.

Gender

ALL

Eligibility criteria

• DISEASE CHARACTERISTICS:
• Biopsy-proven grade I soft tissue sarcoma or one of the following benign but highly invasive soft tissue tumors:
• • Abdominal and extra-abdominal fibromatosis (desmoid,
• • aggressive fibromatosis),
• • Dermatofibrosarcoma protuberans,
• • Intramuscular lipoma (infiltrating lipoma),
• • Diffuse lipomatosis,
• • Leiomyoma of deep soft tissue,
• • Diffuse giant cell tumor of tendon sheath (proliferative synovitis).
• • No clinical evidence of metastases in regional nodes or more distant sites.
• • No primary intraperitoneal or retroperitoneal tumors.
• • Resection of all gross tumor at the time of surgical excision required (margins may be pathologically positive or negative).
• • No von Recklinghausen's disease.
• PRIOR/CONCURRENT THERAPY:
• • Biologic Therapy: Not specified.
• • Chemotherapy: No prior chemotherapy for sarcoma.
• • Endocrine Therapy: Not specified.
• • Radiotherapy: No prior radiotherapy for sarcoma.
• • Surgery: No more than 4 months since definitive surgery for
• • primary lesion or recurrence.
• • No prior amputation.
• PATIENT CHARACTERISTICS:
• • Age: 18 and over.
• • Performance status: Not specified.
• • Hematopoietic: Not specified.
• • Hepatic: No cirrhosis.
• • Renal: No evidence of severe renal impairment.
• • Cardiovascular: No ischemic heart disease.
• OTHER:
• • No prior malignancy except basal cell carcinoma.
• • No serious infection.
• • No active bleeding disorder.
• • No severe concomitant disease.