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



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

For Condition: Sarcoma
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:  Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment: 100

Location and Contact Information:

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


Additional Information:
Study ID Numbers:  830212;  83-C-0212
Study Start Date: December 5, 1983
Record last reviewed: November 1, 1999
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001188

Other Sarcoma Studies:
1. A Randomized Study of Electroacupuncture Treatment for Delayed Chemotherapy-induced Nausea and Vomiting in Patients with Pediatric Sarcomas

2. Pilot Study of a Double Isolation Perfusion Schedule Using Melphalan Alone for Intransit Melanoma or Unresectable Sarcoma of the Extremity

3. A Phase I Study of SU101 in Pediatric Patients with Refractory Malignancy

4. Treating Inoperable Lung Tumors With Heated Chemotherapy Medicine Delivered Solely to the Lung

5. Stem Cell Transplantation in Patients with High-Risk and Recurrent Pediatric Sarcomas

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