Evaluating Cyberknife Radiosurgery for Patients with Multiple Brain Metastases
The CyberChallenge Trial How Much is Too Much - What is the Role of Cyberknife Radiosurgery in Patients With Multiple Brain Metastases?
NA · University Hospital Heidelberg · NCT05378633
This study is testing whether a new type of targeted radiation treatment called Cyberknife can help people with multiple brain tumors live better and longer compared to standard whole-brain radiation therapy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 190 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Heidelberg (other) |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Heidelberg) |
| Trial ID | NCT05378633 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Cyberknife stereotactic radiosurgery (SRS) compared to conventional whole-brain radiotherapy (WBRT) in patients with 4 to 15 brain metastases. The study aims to assess quality-adjusted life-years (QUALY), overall survival, and quality of life as primary endpoints, while also examining secondary outcomes such as daily living activities, progression-free survival, and cognitive function. By focusing on a less toxic treatment option, the trial seeks to improve patient care for those with advanced malignancies and limited life expectancy. Additionally, the study is linked to a translational program that aims to identify biomarkers for personalized treatment.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed malignancies and 4 to 15 brain metastases.
Not a fit: Patients with small-cell lung cancer, lymphoma, or those with more than 15 brain lesions may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could provide a less toxic and more efficient treatment option for patients with multiple brain metastases, potentially improving their quality of life and survival.
How similar studies have performed: Previous studies have shown promising results for SRS in treating brain metastases, suggesting that this approach may be effective, though this specific comparison with WBRT is less established.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Heidelberg
- University Hospital of Heidelberg, Radiation Oncology — Heidelberg, Germany (RECRUITING)
Study contacts
- Principal investigator: Juergen Debus, Prof. — Head of Department
- Study coordinator: Tanja Eichkorn, MD
- Email: tanja.eichkorn@med.uni-heidelbeg.de
- Phone: 06221 56
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Brain Metastases, Nsclc, Metastases, Cyberknife, Lung Cancer