Evaluation of Repeated Whole Brain Radiotherapy Versus Best Supportive Care for Multiple Brain Metastases.
NCT03288272 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2017-09-20
Summary
Whole Brain Radiotherapy (WBRT) has been established as the treatment standard in patients with multiple cerebral metastases from solid tumors. However, intracerebral recurrence is possible and a repeated WBRT may be indicated to improve intracerebral tumor control. Each institutsion offers different dosing regimens, which have all been published to be safe and effective. Some favor best supportive care only.
The current study protocol is aimed at evaluating primarily the toxicity as well as secondarily the local and loco-regional tumor control, overall survival and QoL after repeated WBRT using 2 different dose concepts (20 Gy in 10 Fx vs. 30 Gy in 15 Fx) compared to BSC.
Conditions
- Brain Metastasases
Interventions
- RADIATION
-
Whole Brain Radiotherapy
Radiotherapy of the whole brain
- OTHER
-
Best Supportive Care
Best Supportive Care including nutrition, pain medication, steroids as needed
Sponsors & Collaborators
-
Stephanie Combs
lead OTHER
Principal Investigators
-
Stephanie E Combs, Prof. Dr. · Professor and Department Chair
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-04-30
- Primary Completion
- 2018-05-31
- Completion
- 2018-05-31
Countries
- Germany
Study Locations
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