Status:
COMPLETED
Stereotactic Radiotherapy of the Resection Cavity of Brain Metastases vs. Post-operative Whole-brain Radiotherapy
Lead Sponsor:
Juergen Debus
Collaborating Sponsors:
Heidelberg University
Conditions:
Brain Metastases, Adult
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
In advanced cancer disease brain metastases are common, difficult to treat, and are associated with a poor prognosis. As new local and systemic therapies are eventually resulting in improved survival ...
Detailed Description
Scientific Background: Brain metastases (BM) represent a significant healthcare problem. It is estimated that 20% to 40% of patients with cancer will develop metastatic cancer to the brain during the ...
Eligibility Criteria
Inclusion
- histologically confirmed solid cancer
- MRI confirmed cerebral metastases
- Neurosurgical resection of one cerebral metastasis
- age ≥ 18 years of age
- Karnofsky Performance Score \>60
- for women with childbearing potential, (and men) adequate contraception.
- ability to understand character and individual consequences of the clinical trial
- written informed consent (must be available before enrolment in the trial)
Exclusion
- refusal of the patients to take part in the study
- previous radiotherapy to the brain
- \> 10 unresected brain metastases in postoperative MRI
- Patients who have not yet recovered from acute toxicities of prior therapies
- known carcinoma \< 2 years ago (excluding carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy
- pregnant or lactating women
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 8 2021
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT03285932
Start Date
February 1 2018
End Date
July 8 2021
Last Update
November 3 2022
Active Locations (1)
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1
Department of Radiotherapy, University of Heidelberg
Heidelberg, Germany, 69120