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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

Primary Purpose

Brain Neoplasms

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
irradiation
radiosurgery
Sponsored by
National Institute of Neurological Disorders and Stroke (NINDS)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Neoplasms focused on measuring adult brain tumor, brain tumor, childhood brain tumor, genetic condition, nervous tissue tumors, oncologic disorders, rare disease

Eligibility Criteria

0 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 24, 2000
    Last Updated
    June 23, 2005
    Sponsor
    National Institute of Neurological Disorders and Stroke (NINDS)
    Collaborators
    University of Pittsburgh
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00004659
    Brief Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 1999
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 1994 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Institute of Neurological Disorders and Stroke (NINDS)
    Collaborators
    University of Pittsburgh

    4. Oversight

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Brain Neoplasms
    Keywords
    adult brain tumor, brain tumor, childhood brain tumor, genetic condition, nervous tissue tumors, oncologic disorders, rare disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Allocation
    Randomized
    Enrollment
    40 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    irradiation
    Intervention Type
    Procedure
    Intervention Name(s)
    radiosurgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    0 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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%
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Douglas Kondziolka
    Organizational Affiliation
    University of Pittsburgh
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this 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

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