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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00001188
Enrollment
100
Registered
2002-12-10
Start date
1983-12-31
Completion date
2000-09-30
Last updated
2008-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcoma

Keywords

Chemotherapy, Radiation Therapy, Sarcoma, Surgery

Brief summary

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.

Detailed 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.

Interventions

PROCEDUREradiation therapy following surgery

Sponsors

National Cancer Institute (NCI)
Lead SponsorNIH

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026