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Phase II Randomized Study of Stereotactic Radiosurgery Plus Fractionated Whole-Brain Radiotherapy vs Fractionated Whole-Brain Radiotherapy Alone for Multiple Primary or Metastatic Brain Tumors - Article


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Brain and Nerves

 




Clinical Trial: Phase II Randomized Study of Stereotactic Radiosurgery Plus Fractionated Whole-Brain Radiotherapy vs Fractionated Whole-Brain Radiotherapy Alone for Multiple Primary or Metastatic Brain Tumors

This study is no longer recruiting patients.

Sponsors and Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
University of Pittsburgh
Information provided by: Office of Rare Diseases (ORD)

Purpose

OBJECTIVES: I. Evaluate whether stereotactic radiosurgery provides local control at multiple sites in patients with primary or metastatic brain tumors, controlled systemic disease, and preserved neurologic function. II. Examine survival, clinical outcome, and local tumor imaging response in these patients.

Condition Treatment or Intervention Phase
Brain Neoplasms
 Procedure: irradiation
 Procedure: radiosurgery
Phase II

MedlinePlus related topics:  Brain Cancer

Study Type: Interventional
Study Design: Treatment, Randomized

Further Study Details: 

Expected Total Enrollment:  40

Study start: November 1994

PROTOCOL OUTLINE: This is a randomized study. Tumor size and number are confirmed prior to randomization. Patients are stratified by participating institution. Patients are randomly assigned to 1 of 2 treatment groups. One group is treated with fractionated whole-brain irradiation using megavoltage equipment. The second group receives stereotactic radiosurgery plus fractionated whole-brain radiotherapy. Stereotactic radiosurgery involves irradiation of all tumors to the margins on stereotactic computerized tomography or magnetic resonance imaging. Either treatment may be administered first; the second treatment begins within 1 month of the first. Concurrent anticonvulsants and steroids are allowed. Patients are followed for change in size and number of tumors at 1, 3, and 6 months; follow-up clinical exams are performed at least every 2 months.

Eligibility

Genders Eligible for Study:  Both

Criteria

  • Multiple newly diagnosed brain tumors
  • Histologic confirmation of carcinoma at primary or metastatic site
  • Tumors less than 25 mm mean diameter and more than 5 mm from optic chiasm
  • No more than 4 tumors on magnetic resonance imaging
  • Systemic disease controlled
  • Neurologic function preserved
  • Radiographic staging within 2 months of randomization required
  • Performance status: Karnofsky 70%-100%

Location Information

Study chairs or principal investigators

Douglas Kondziolka,  Study Chair,  University of Pittsburgh   

More Information

Study ID Numbers:  199/11858; UPPUH-9511117
Record last reviewed:  March 1999
Last Updated:  October 13, 2004
Record first received:  February 24, 2000
ClinicalTrials.gov Identifier:  NCT00004659
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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November 27, 2009



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