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


Phase 2
N/A
N/A
Not Enrolling
Both
Sarcoma

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Trial Information

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


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.

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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Authority:

United States: Federal Government

Study ID:

830212

NCT ID:

NCT00001188

Start Date:

December 1983

Completion Date:

September 2000

Related Keywords:

  • Sarcoma
  • Chemotherapy
  • Radiation Therapy
  • Sarcoma
  • Surgery
  • Sarcoma

Name

Location

National Cancer Institute (NCI)Bethesda, Maryland  20892