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

Official Title: “The Role of Multi-Modality Therapy for the Treatment of High-Grade Soft Tissue Sarcomas of the Extremities”

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.

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.

Intervention(s) in this Clinical Trial

• Procedure: radiation therapy following surgery

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: National Cancer Institute (NCI) NIH

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00001188

Study ID Number: 830212

ClinicalTrials.gov Identifier: NCT00001188

Health Authority: United States: Federal Government