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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

1994-11-30

Brief Summary

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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

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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.

Conditions

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Brain Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Interventions

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irradiation

Intervention Type PROCEDURE

radiosurgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion 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%

Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Douglas Kondziolka

Role: STUDY_CHAIR

University of Pittsburgh

Other Identifiers

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UPPUH-9511117

Identifier Type: -

Identifier Source: secondary_id

199/11858