The Role of Multi-Modality Therapy for the Treatment of High-Grade Soft Tissue Sarcomas of the Extremities

March 3, 2008 updated by: National Cancer Institute (NCI)
Patients with Grade II and III soft tissue sarcomas of the extremity will be randomized to either receive or not receive radiation therapy following surgery for the removal of the local tumor. All patients in this protocol will receive adjuvant chemotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with Grade II and III soft tissue sarcomas of the extremity will be randomized to either receive or not receive radiation therapy following surgery for the removal of the local tumor. All patients in this protocol will receive adjuvant chemotherapy.

Study Type

Interventional

Enrollment

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Cancer Institute (NCI)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Patients must have biopsy-proven soft tissue sarcoma with one of the following diagnoses:

Liposarcoma (round cell or pleomorphic).

Fibrosarcoma.

Malignant fibrous histiocytoma.

Inflammatory malignant fibrous histiocytoma.

Myxoid malignant fibrous histiocytoma.

Malignant giant cell tumor.

Angiomatoid malignant fibrous histiocytoma.

Leiomyosarcoma.

Malignant hemangiopericytoma.

Rhabdomyosarcoma (embryonal, alveolar, pleomorphic or combined).

Soft tissue sarcoma resembling Ewing's sarcoma.

Synovial cell sarcoma.

Epithelioid sarcoma.

Clear cell sarcoma.

Neurofibrosarcoma.

Epithelioid schwannoma.

Malignant triton tumor.

Angiosarcoma.

Mixed malignant mesenchymoma.

Alvelar soft part sarcoma.

Malignant granular cell tumor.

All lesions must be Grade II or III. No patients with Grade I lesions will be acceptable.

Patients must have undergone a limb-sparing procedure in which all gross tumor has been removed.

Clinical evaluation must reveal no evidence of metastatic disease either in regional lymph nodes or more distant sites.

The soft tissue sarcoma must be on the extremity either at or distal to the shoulder joint or at or distal to the hip joint.

The definitive surgical procedure for a primary lesion or for a recurrence must have been performed no longer than four months from the date of randomization.

Patients must not have received any prior chemotherapy or radiotherapy for their sarcoma.

Patients without a history of any other malignant disease except basal cell carcinoma.

Patients who have not had a serious infection, active bleeding disorders, or concomitant severe disease such as cirrhosis, ischemic heart disease, or evidence of severe impairment of renal function.

Patients must be above the age of 30 and do not have a diagnosis of embryonal rhabdomyosarcoma.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1983

Study Completion

September 1, 2000

Study Registration Dates

First Submitted

November 3, 1999

First Submitted That Met QC Criteria

December 9, 2002

First Posted (Estimate)

December 10, 2002

Study Record Updates

Last Update Posted (Estimate)

March 4, 2008

Last Update Submitted That Met QC Criteria

March 3, 2008

Last Verified

November 1, 1999

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 830212
  • 83-C-0212

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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