Status:
COMPLETED
The Treatment of Grade I Sarcomas and Benign, Non-Metastasizing Highly Invasive Soft Tissue Tumors
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Sarcoma
Neoplasms
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
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...
Detailed Description
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 tr...
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.
Key Trial Info
Start Date :
December 1 1983
Trial Type :
INTERVENTIONAL
End Date :
April 1 2001
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00001189
Start Date
December 1 1983
End Date
April 1 2001
Last Update
March 4 2008
Active Locations (1)
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1
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892