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

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001189
• Other study ID #: 830227
• Secondary ID: 83-C-0227
• Status: Completed
• Phase: Phase 2
• First received: November 3, 1999
• Last updated: March 3, 2008
• Start date: December 1983
• Est. completion date: April 2001

Study information

• Verified date: May 2000
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms
• Sarcoma
• Soft Tissue Neoplasms

Intervention

Procedure:
• radiotherapy

Locations

Country	Name	City	State
United States	National Cancer Institute (NCI)	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Wara WM, Phillips TL, Hill DR, Bovill E Jr, Luk KH, Lichter AS, Leibel SA. Desmoid tumors--treatment and prognosis. Radiology. 1977 Jul;124(1):225-6. — View Citation