NCT05378633 The CyberChallenge Trial How Much is Too Much - What is the Role of Cyberknife Radiosurgery in Patients With Multiple Brain Metastases?
| NCT ID | NCT05378633 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital Heidelberg |
| Condition | Brain Metastases |
| Study Type | INTERVENTIONAL |
| Enrollment | 190 participants |
| Start Date | 2022-02-24 |
| Primary Completion | 2027-02-24 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 190 participants in total. It began in 2022-02-24 with a primary completion date of 2027-02-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility 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)
Contact & Investigator
Juergen Debus, Prof.
PRINCIPAL INVESTIGATOR
Head of Department
Frequently Asked Questions
Who can join the NCT05378633 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Brain Metastases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05378633 currently recruiting?
Yes, NCT05378633 is actively recruiting participants. Contact the research team at tanja.eichkorn@med.uni-heidelbeg.de for enrollment information.
Where is the NCT05378633 trial being conducted?
This trial is being conducted at Heidelberg, Germany.
Who is sponsoring the NCT05378633 clinical trial?
NCT05378633 is sponsored by University Hospital Heidelberg. The principal investigator is Juergen Debus, Prof. at Head of Department. The trial plans to enroll 190 participants.