Supportive Care With or Without Repeated Whole Brain Radiotherapy in Patients With Recurrent Brai… (NCT04084431) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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