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Supportive Care With or Without Repeated Whole Brain Radiotherapy in Patients With Recurrent Brain Metastases
Sponsor: University Hospital Heidelberg
Summary
Patients with solid cancers may develop cerebral metastases, requiring whole brain radiotherapy (WBRT). Furthermore, in several cases, a secondary course of WBRT might be required due to intracerebral recurrence and limited options for alternative treatments, besides optimal supportive care (OSC). There have been few reports on re-irradiation of the whole brain, but further evaluation especially of the optimal dose concept is warranted. Especially, the efficacy compared to OSC has to date not been evaluated. The present trial aims at evaluating the efficacy of a repeated WBRT with a total dose of 20 Gy in 10 fractions compared to OSC. Primary endpoint is time to WHO performance status (PS) deterioration to more than 3 (duration of functional independence). Secondary endpoints are quality of life, overall survival, radiation-induced toxicity and functional independence assessed by the Barthel Index of Activities of Daily Living (ADL)1.
Official title: Supportive Care With or Without Repeated Whole Brain Radiotherapy in Patients With Recurrent Brain Metastases Unsuitable for Resection or Stereotactic Radiotherapy.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
0
Start Date
2019-07-01
Completion Date
2025-07-01
Last Updated
2026-05-05
Healthy Volunteers
No
Conditions
Interventions
Radiation
WBRT will be applied in 10 fractions with single doses of 2 Gy (Arm 1) to the whole brain
OSC
optimal supportive Care (OSC) alone
Locations (1)
University Hospital
Heidelberg, Germany