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 ongoing, but not recruiting participants.

First Received: February 24, 2000 Last Updated: June 23, 2005 History of Changes

Sponsors and Collaborators:	National Institute of Neurological Disorders and Stroke (NINDS) University of Pittsburgh
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004659

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	Intervention	Phase
Brain Neoplasms	Procedure: irradiation Procedure: radiosurgery	Phase II

MedlinePlus related topics: Brain Cancer Cancer Childhood Brain Tumors Radiation Therapy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment:	40
Study Start Date:	November 1994

Detailed Description:

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
Accepts Healthy Volunteers:	No

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%

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004659

Sponsors and Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

University of Pittsburgh

Investigators

Study Chair:

Douglas Kondziolka

University of Pittsburgh

More Information

No publications provided

Study ID Numbers:	199/11858, UPPUH-9511117
Study First Received:	February 24, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004659 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):

adult brain tumor
brain tumor
childhood brain tumor
genetic condition

nervous tissue tumors
oncologic disorders
rare disease

Study placed in the following topic categories:

Brain Neoplasms
Rare Diseases
Brain Tumor, Childhood
Central Nervous System Diseases

Central Nervous System Neoplasms
Brain Diseases
Nervous System Neoplasms

Additional relevant MeSH terms:

Brain Neoplasms
Neoplasms
Neoplasms by Site
Nervous System Diseases

Central Nervous System Diseases
Central Nervous System Neoplasms
Brain Diseases
Nervous System Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009