Randomized Trial Comparing Radiosurgery With vs Without Whole Brain Radiotherapy

NCT00548756 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2023-06-07

No results posted yet for this study

Summary

The goal of this clinical research study is to learn if your thinking ability (cognitive function) will be better preserved by delivering whole brain radiation therapy immediately after radiosurgical treatment of 1-3 brain metastases or to carefully observe patients after radiosurgery and hold back whole brain radiation therapy until the disease comes back.

Conditions

Interventions

PROCEDURE

Whole Brain Radiation Therapy

Whole Brain Radiation Therapy. Total dose = 30 Gy over 12 fractions at 2.5Gy per fraction.

OTHER

Observation

Patients who did not receive whole brain radiation and develop recurrent disease shall receive treatment based on the number of lesions.

BEHAVIORAL

Questionnaire

Questionnaire taking 40 minutes to complete.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • David L. Grosshans, MD,PHD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-01-02
Primary Completion
2023-06-02
Completion
2023-06-02

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00548756 on ClinicalTrials.gov