Search / Trial NCT00001188

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

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Trial Information

Current as of May 26, 2024

Completed

Keywords

Chemotherapy Radiation Therapy Sarcoma Surgery

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

readout_NCT00001188_2024-05-26.pdf

4.5 MB

NCT00001188_study_protocol.pdf

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

JC

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)

4.6

All reviews come from applied patients

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Leslie Alexander
20 September 2023

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?

Michael Foster
20 September 2023

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?

Dries Vincent
20 September 2023

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?

Leslie Alexander
20 September 2023

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?

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