Evaluating Cyberknife Radiosurgery for Patients with Multiple Brain Metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.