Randomized Trial Comparing Radiosurgery With vs Without Whole Brain Radiotherapy
NCT00548756 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 152
Last updated 2023-06-07
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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