Patients with Grade I soft tissue sarcomas or benign, non-metastasizing invasive soft tissue
tumors will receive wide local excision and be prospectively randomized as to either receive
or not receive radiation therapy.
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.
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,
Intramuscular lipoma (infiltrating lipoma),
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.
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.
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.
No prior malignancy except basal cell carcinoma.
No serious infection.
No active bleeding disorder.
No severe concomitant disease.