WithdrawnNot Applicable

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

Stopped: Organizational Reasons

Germany0Started 2019-07-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * histologically confirmed malignancy * previous WBRT or prophylactic whole brain irradiation (PCI) * MR- or CT-imaging confirmed recurrent cerebral metastases (\>10) * Or: MR- or CT-imaging confirmed recurrent cerebral metastases (1-10) and inability to perform SRS or surgery (e.g. meningeal carcinomatosis), concluded by interdisciplinary conference * age ≥ 18 years * Time between initial WBRT/PCI and recurrent WBRT \>3 months * WHO performance score ≤3 * For women with childbearing potential, (and men) adequate contraception. * Ability of subject to understand character and individual consequences of the clinical trial * Written informed consent (must be available before enrolment in the trial) Exclusion Criteria: * • refusal to take part in the study * Pregnant or lactating women * Participation in another competing clinical study or observation period of competing trials, respectively * Ability to perform SRS or surgery on brain metastases as a treatment alternative * Systemic anticancer treatment \<4 weeks for chemotherapy and \<1 week for TKIs and targeted therapies before randomisation. * Persons who are in a relationship of dependence/employment with the investigators * Cerebral lymphomas, metastases of germ cell tumours

What they're measuring

Time to WHO PS to more than 3

Timeframe: up to 4 years or from date of randomization unitl the date of documented date of death from any cause

Trial details

NCT IDNCT04084431

SponsorUniversity Hospital Heidelberg

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-01