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WITHDRAWN
NCT04084431
NA

Supportive Care With or Without Repeated Whole Brain Radiotherapy in Patients With Recurrent Brain Metastases

Sponsor: University Hospital Heidelberg

View on ClinicalTrials.gov

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

Interventions

RADIATION

Radiation

WBRT will be applied in 10 fractions with single doses of 2 Gy (Arm 1) to the whole brain

OTHER

OSC

optimal supportive Care (OSC) alone

Locations (1)

University Hospital

Heidelberg, Germany