Sarcoma of soft tissue: clinical and histopathologic parameters and response to treatment.
H D Suit, W O Russell, R G Martin
https://pubmed.ncbi.nlm.nih.gov/1122498Completed
Phase 2
All Genders
ID00001188
The Role of Multi-Modality Therapy for the Treatment of High-Grade Soft Tissue Sarcomas of the Extremities
Led by National Cancer Institute (NCI) · Updated on 2008-03-04
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Role of Multi-Modality Therapy for the Treatment of High-Grade Soft Tissue Sarcomas of the Extremities
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 1 location
1
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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Published Research Related To This Trial
Conservative surgery and postoperative radiotherapy in 300 adults with soft-tissue sarcomas.
R D Lindberg, R G Martin, M M Romsdahl...
https://pubmed.ncbi.nlm.nih.gov/7272893Effectiveness of radiation therapy in the management of sarcoma of the soft somatic tissues.
G P McNeer, J Cantin, F Chu...
https://pubmed.ncbi.nlm.nih.gov/4298242