Status:
SUSPENDED
Supportive Care With or Without Repeated Whole Brain Radiotherapy in Patients With Recurrent Brain Metastases
Lead Sponsor:
University Hospital Heidelberg
Conditions:
Brain Metastases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed Description
According to Nussbaum et al., 24-45% of cancer patients develop cerebral metastases during their disease. Brain metastases are generally associated with a poor prognosis and high morbidity2. Published...
Eligibility Criteria
Inclusion
- 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
- • 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
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04084431
Start Date
July 1 2019
End Date
July 1 2025
Last Update
January 5 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital
Heidelberg, Germany, 69120