Status:
UNKNOWN
Evaluation of Repeated Whole Brain Radiotherapy Versus Best Supportive Care for Multiple Brain Metastases.
Lead Sponsor:
Stephanie Combs
Conditions:
Brain Metastasases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Whole Brain Radiotherapy (WBRT) has been established as the treatment standard in patients with multiple cerebral metastases from solid tumors. However, intracerebral recurrence is possible and a repe...
Detailed Description
According to Nussbaum et al., 24-45% of cancer patients develop cerebral metastases during the course of the disease. Brain metastases are generally associated with a poor prognosis and high morbidity...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- histologically confirmed malignancy
- previous WBRT
- MR-imaging confirmed cerebral metastases (\>1)
- age ≥ 18 years of age
- Karnofsky Performance Score ³60
- 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 of the patients to take part in the study
- Patients who have not yet recovered from acute high-grade toxicities of prior therapies
- Pregnant or lactating women
- Participation in another clinical study or observation period of competing trials, respectively
Exclusion
Key Trial Info
Start Date :
April 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2018
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03288272
Start Date
April 1 2016
End Date
May 1 2018
Last Update
September 20 2017
Active Locations (1)
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1
Technische Universität München (TUM), Klinikum rechts der Isar
Munich, Germany, 81675