The Role of Multi-Modality Therapy for the Treatment of High-Grade Soft Tissue Sarcomas of the Extremities
Data Collection
Neoplasms+1
+ Neoplasms by Histologic Type
+ Sarcoma
Treatment Study
Summary
Study start date: December 1, 1983
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.100 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
National Cancer Institute (NCI)
Bethesda, United StatesOpen National Cancer Institute (NCI) in Google Maps