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Total Body Irradiation for Bone Marrow Transplants: Collaborative Efforts

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00026858
First received: November 14, 2001
Last updated: March 3, 2008
Last verified: November 2002
History of Changes
  Purpose

Most bone marrow transplantations for malignant and non-malignant disease include whole body irradiation. Techniques for administering that treatment, including patient positioning, lung and soft tissue compensation, dose rate, total dose and fractionation differ between institutions. These differences are optimized at each institution to limit toxicity and maximize therapeutic outcome.

Technically complex procedures such as total body radiation are subject to equipment failures. Such failures mid-treatment could be catastrophic to the patient, since therapy must be timely and compatible therapy may not be available elsewhere in the community. The purpose of this protocol is to provide backup between George Washington University Medical Center and the Radiation Oncology Branch of the NCI to allow for orderly, safe, and compatible therapies in the event of equipment failure; or replacement of a linear accelerator or any other malfunctioning equipment necessary to deliver TBI; or any emergent situation.


Condition Intervention Phase
Neoplasm
 Behavioral: collaboration
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Treatment
Official Title: Total Body Irradiation for Bone Marrow Transplants: Collaborative Efforts

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 100
Study Start Date: October 1994
Estimated Study Completion Date: November 2002
Detailed Description:

Most bone marrow transplantations for malignant and non-malignant disease include whole body irradiation. Techniques for administering that treatment, including patient positioning, lung and soft tissue compensation, dose rate, total dose and fractionation differ between institutions. These differences are optimized at each institution to limit toxicity and maximize therapeutic outcome.

Technically complex procedures such as total body radiation are subject to equipment failures. Such failures mid-treatment could be catastrophic to the patient, since therapy must be timely and compatible therapy may not be available elsewhere in the community. The purpose of this protocol is to provide backup between George Washington University Medical Center and the Radiation Oncology Branch of the NCI to allow for orderly, safe, and compatible therapies in the event of equipment failure; or replacement of a linear accelerator or any other malfunctioning equipment necessary to deliver TBI; or any emergent situation.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

Patients must sign informed consent.

Supporting institution physicians must agree that therapy is appropriate and safe.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00026858

Locations
United States, Maryland
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00026858     History of Changes
Other Study ID Numbers: 950003, 95-C-0003
Study First Received: November 14, 2001
Last Updated: March 3, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Bone Marrow Transplantation
Leukemia
Breast Cancer
Multiple Myeloma
Total Body Irradiation

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on May 19, 2013