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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00001189
Enrollment
150
Registered
2002-12-10
Start date
1983-12-31
Completion date
2001-04-30
Last updated
2008-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasms, Sarcoma

Keywords

Adjuvant Radiotherapy, Low-Grade Sarcoma, Radiotherapy, Randomized Study, Sarcoma, Surgery

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 radiation therapy.

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 treatment.

Interventions

PROCEDUREradiotherapy

Sponsors

National Cancer Institute (NCI)
Lead SponsorNIH

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026