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

Primary Purpose

Sarcoma, Neoplasms

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
radiotherapy
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring Adjuvant Radiotherapy, Low-Grade Sarcoma, Radiotherapy, Randomized Study, Sarcoma, Surgery

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Cancer Institute (NCI)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00001189
Brief Title
The Treatment of Grade I Sarcomas and Benign, Non-Metastasizing Highly Invasive Soft Tissue Tumors
Official Title
The Treatment of Grade I Sarcomas and Benign, Non-Metastasizing Highly Invasive Soft Tissue Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
May 2000
Overall Recruitment Status
Completed
Study Start Date
December 1983 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2001 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma, Neoplasms
Keywords
Adjuvant Radiotherapy, Low-Grade Sarcoma, Radiotherapy, Randomized Study, Sarcoma, Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
150 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
radiotherapy

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
National Cancer Institute (NCI)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
405711
Citation
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. doi: 10.1148/124.1.225.
Results Reference
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The Treatment of Grade I Sarcomas and Benign, Non-Metastasizing Highly Invasive Soft Tissue Tumors

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