The Role of Multi-Modality Therapy for the Treatment of High-Grade Soft Tissue Sarcomas of the Extremities
Launched by NATIONAL CANCER INSTITUTE (NCI) · Dec 9, 2002
Trial Information
Current as of November 28, 2023
Completed
Keywords
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.
Gender
All
Eligibility 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.
Attachments
4.5 MB
4.5 MB
About company
The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Bethesda, Maryland, United States
People applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Reviews (48)
All reviews come from applied patients

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?
Discussion 0