Status:
COMPLETED
Cyberknife Radiosurgery for Patients With Brain Metastases Diagnosed With Either SPACE or MPRAGE Sequence
Lead Sponsor:
Juergen Debus
Collaborating Sponsors:
Heidelberg University
Conditions:
Brain Metastases
Adult Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
For patients with cerebral oligometastases who are in adequate clinical condition stereotactic radiosurgery (SRS) is the treatment of choice, being recommended by international guidelines for the trea...
Detailed Description
Scientific Background: Brain metastases are the most common intracranial cancer manifestations, affecting up to one third of adult cancer patients with systemic spread. Prognosis is generally poor wit...
Eligibility Criteria
Inclusion
- radiologically confirmed metastases of the brain with an underlying history of a malignant illness
- between one and ten suspect intracranial lesions, taking into consideration all available series of the pre-therapeutic MRI (performed at Heidelberg University Hospital and including SPACE sequence)
- age ≥ 18 years of age
- Karnofsky Performance Score (KPS) ≥ 70
- 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 patient to take part in the study
- Small-cell lung cancer (SCLC) as primary malignant illness
- More than 10 suspect intracranial lesions in the initial pre-therapeutic MRI imaging (performed at Heidelberg University Hospital and including SPACE sequence)
- metastasis so close to OAR that initial single-session SRS would be impossible due to lacking radiotolerance
- known contraindications against the performing of cranial MRI
- previous radiotherapy of the brain
- Patients who have not yet recovered from acute toxicities of prior therapies
- Pregnant or lactating women
- Participation in another clinical study or observation period of competing trials, respectively
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2021
Estimated Enrollment :
203 Patients enrolled
Trial Details
Trial ID
NCT03303365
Start Date
February 1 2018
End Date
June 1 2021
Last Update
November 3 2022
Active Locations (1)
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1
University Hospital of Heidelberg, Department of Radiation Oncology
Heidelberg, Germany, 69120