Trials / Recruiting
RecruitingNCT05378633
The CyberChallenge Trial How Much is Too Much - What is the Role of Cyberknife Radiosurgery in Patients With Multiple Brain Metastases?
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 190 (estimated)
- Sponsor
- University Hospital Heidelberg · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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 brain metastases is to be prospectively investigated. The effect will be measured using quality-adjusted life-years (QUALY). Quality of life and overall survival are therefore primary endpoints. Secondary endpoints are the ability to perform basic activities of daily life (Barthel (ADL) index), progression-free survival, local and locoregional progression-free survival, extracranial progression, toxicity and its treatment, the recording of postherapeutic radiation-induced brain lesions (RIBL), long-term cognitive function, a possible salvage therapy as well as death from brain metastases. Furthermore, die CyberChallenge trial is linked to a translational program via BUB2 study. The BUB2 study conducts biobanking of blood, urine and resection or biopsy material, if available, as well as collects imaging material. This is to find diagnostic and prognostic biomarkers in our cancer patients via analyzing genetic, epigenetic and protein expression patterns as well as radiomics and correlating them to clinical data and therefore further push individualized patient care in brain metastases forward.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | SRS | Stereotactic Radiotherapy (SRS) |
| RADIATION | Whole Brain Radiotherapy | Whole Brain Radiotherapy (WBRT) |
Timeline
- Start date
- 2022-02-24
- Primary completion
- 2027-02-24
- Completion
- 2028-02-24
- First posted
- 2022-05-18
- Last updated
- 2026-03-10
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT05378633. Inclusion in this directory is not an endorsement.