Status:
RECRUITING
The CyberChallenge Trial How Much is Too Much - What is the Role of Cyberknife Radiosurgery in Patients With Multiple Brain Metastases?
Lead Sponsor:
University Hospital Heidelberg
Conditions:
Brain Metastases
Nsclc
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Patients suffering from malignancies in advanced stages often develop brain metastases, which limit both the life span and the quality of life. Therapy options for multiple brain metastases may vary ...
Detailed Description
In the present multicenter study, the benefit of SRS compared to conventional whole brain radiotherapy, each combined with best supportive care or best supportive care only, in patients with 4-15 brai...
Eligibility Criteria
Inclusion
- histologically confirmed malignant illness
- 4-15 suspect intracranial lesions, taking into consideration all available MRI series
- age ≥ 18 years of age
- 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 of the patients to take part in the study
- Inability to tolerate irradiation consistent with the protocol
- Small-cell lung cancer (SCLC) or lymphoma as primary malignant illness
- \>15 suspect intracranial lesions, taking into consideration all available MRI series
- leptomeningeal disease
- Previous radiotherapy of the brain
- Patients who have not yet recovered from acute high-grade toxicities of prior therapies
- Pregnant or lactating women
- Participation in another competing clinical study or observation period of competing trials, respectively
- MRI contraindication (i.e. cardiac pacemaker, implanted defibrillator, certain cardiac valve replacements, certain metal implants)
Key Trial Info
Start Date :
February 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 24 2026
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT05378633
Start Date
February 24 2022
End Date
February 24 2026
Last Update
January 5 2024
Active Locations (1)
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1
University Hospital of Heidelberg, Radiation Oncology
Heidelberg, Germany, 69120