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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00001189
Recruitment Status : Completed
First Posted : December 10, 2002
Last Update Posted : March 4, 2008
Information provided by:
National Institutes of Health Clinical Center (CC)

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.

Condition or disease Intervention/treatment Phase
Sarcoma Neoplasms Procedure: radiotherapy Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
Primary Purpose: Treatment
Official Title: The Treatment of Grade I Sarcomas and Benign, Non-Metastasizing Highly Invasive Soft Tissue Tumors
Study Start Date : December 1983
Study Completion Date : April 2001

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


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.


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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00001189

United States, Maryland
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)

Publications: Identifier: NCT00001189     History of Changes
Other Study ID Numbers: 830227
First Posted: December 10, 2002    Key Record Dates
Last Update Posted: March 4, 2008
Last Verified: May 2000

Keywords provided by National Institutes of Health Clinical Center (CC):
Adjuvant Radiotherapy
Low-Grade Sarcoma
Randomized Study

Additional relevant MeSH terms:
Soft Tissue Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms by Site