The CyberChallenge Trial How Much is Too Much - What is the Role of Cyberknife Radiosurgery in Patients With Multiple Brain Metastases?
Recruiting · NCT05378633 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital Heidelberg
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 and range from stereotactic radiosurgery (SRS), whole-brain radiotherapy (WBRT), chemotherapy, immunotherapy to palliative best supportive care. Especially the efficacy and toxicity of SRS compared to WBRT in patients with extensive brain metastases (\>4) is not yet clear but of incremental relevance in this seriously ill cohort with a limited life span. These health-impaired patients might especially profit from a less toxic treatment that is also time sparing with 1 or few sessions in SRS versus 10 sessions in WBRT. On the other hand, no compromises in efficacy want to be done.
Who can take part
Inclusion criteria
- 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 criteria
- 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)
Where it is running
1 location listed.
- University Hospital of Heidelberg, Radiation Oncology - Heidelberg, Germany