Brain MetastasesCyberChallengeNCT05378633
The CyberChallenge Trial How Much is Too Much - What is the Role of Cyberknife Radiosurgery in Patients With Multiple Brain Metastases?
A study testing SRS and Whole Brain Radiotherapy in people with Brain Metastases and Nsclc, run by University Hospital Heidelberg at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Metastases, Nsclc
- What is being tested?
- SRS and Whole Brain Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteGermany
- Study dates
- 24 Feb 2022to 24 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital of Heidelberg, Radiation Oncology
Heidelberg, 69120
Jürgen Debus, Prof. Dr., +49-6221-56 ext. 8202, juergen.debus@med.uni-heidelberg.de
Adriane Hommertgen, +49-6221-56 ext. 34091, adriane.hommertgen@med.uni-heidelberg.de
About this study
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.
Read the 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
- Brain Metastases, Nsclc
- Being tested
- SRS, Whole Brain Radiotherapy
- Keywords
- Metastases, Cyberknife, Lung Cancer
- Medical subject headings
- Brain Neoplasms, Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRSRadiation
Stereotactic Radiotherapy (SRS)
Whole Brain RadiotherapyRadiation
Whole Brain Radiotherapy (WBRT)
| Study group | Role | What they receive |
|---|---|---|
| Experimental Treatment Arm | Experimental | Best Supportive Care + Stereotactic Radiotherapy of all Brain Metastases Receives: Radiation: SRS |
| Standard Treatment Arm | Other | Best Supportive Care ± Whole Brain Radiotherapy Receives: Radiation: Whole Brain Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
number of alive patients
Measured: time from randomisation until the date of death from any cause, assesd up to 24 month
quality of life according to QLQ-C15 (questionaire for patients with advanced cancer referred for palliative radiotherapy
changes in QLQ-C15 scores, scale is 1-100 points, 100 points representing maximum score
Measured: time from randomisation until the date of death from any cause, assesd up to 24 month
quality of life according to BN-20 (questionaire for patients with brain neoplasm)
changes in BN-20 scores, scale is 1-100 points, 100 points representing maximum score
Measured: time from randomisation until the date of death from any cause, assesd up to 24 month
Secondary outcomes (10)
functional independence assessed by the Barthel ADL index
Changes in Barthel ADL index scores, scale 0-100 points
Measured: time from randomisation until the date of death from any cause, assesd up to 24 month
long-term cognitive Status (Hopkins Verbal Learning Test HVLT)
Changes in HVLT scores (minimum 0, maximum 12)
Measured: time from randomisation until the date of death from any cause, assesd up to 24 month
development of radiation-induced brain lesions
changes in amounts of Radiation-induced brain lesions
Measured: time from randomisation until the date of death from any cause, assesd up to 24 month
Radiation induced sideeffects
changes in toxicity rates according to CTCAE 5.0
Measured: time from randomisation until the date of death from any cause, assesd up to 24 month
Overall survival
amount of alive randomized patients enrolled in the trial
Measured: time from randomisation until the date of death from any cause, assesd up to 24 month
local progression of treated metastases
detectable progressive disease of treated metastases
Measured: time from randomisation until the date of death from any cause, assesd up to 24 month
intracranial progression of leptomeningeal disease
occurrence of leptomeningeal disease
Measured: time from randomisation until the date of death from any cause, assesd up to 24 month
intracranial progression of treated BM disease
recurrence of treated BM disease
Measured: time from randomisation until the date of death from any cause, assesd up to 24 month
intracranial progression of new BM disease
occurrence of new BM disease
Measured: time from randomisation until the date of death from any cause, assesd up to 24 month
Brain salvage during follow-up
medical idication for whole brain Radiation after inital stereotactic radiotherapy
Measured: time from randomisation until the date of death from any cause, assesd up to 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start24 Feb 2022
- Primary completion24 Feb 2027 (estimated)
- Study completion24 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MetastasesStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juergen Debus, University Hospital Heidelberg
- Investigators
- Juergen Debus, Prof., Principal investigator, Head of Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05378633
- Sponsor's protocol ID
- The CyberChallenge Trial
- Acronym
- CyberChallenge
- Status last verified
- Mar 2026
- First submitted
- 24 Jan 2022
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CyberChallenge Trial How Much is Too Much - What is the Role of Cyberknife Radiosurgery in Patients With Multiple Brain Metastases?
- ClinicalTrials.gov ID
- NCT05378633
- Acronym / sponsor ID
- CyberChallenge / The CyberChallenge Trial
- Conditions
- Brain Metastases, Nsclc
- Keywords
- Metastases, Cyberknife, Lung Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- 24 Feb 2027 (estimated)
- Study completion
- 24 Feb 2028 (estimated)
- First posted
- 18 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Treatment Arm | Experimental | Radiation: SRSBest Supportive Care + Stereotactic Radiotherapy of all Brain Metastases |
| Standard Treatment Arm | Other | Radiation: Whole Brain RadiotherapyBest Supportive Care ± Whole Brain Radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SRSStereotactic Radiotherapy (SRS) | Radiation | Experimental Treatment Arm |
| Whole Brain RadiotherapyWhole Brain Radiotherapy (WBRT) | Radiation | Standard Treatment Arm |
Primary outcome
overall survival
Time frame: time from randomisation until the date of death from any cause, assesd up to 24 month
number of alive patients
quality of life according to QLQ-C15 (questionaire for patients with advanced cancer referred for palliative radiotherapy
Time frame: time from randomisation until the date of death from any cause, assesd up to 24 month
changes in QLQ-C15 scores, scale is 1-100 points, 100 points representing maximum score
quality of life according to BN-20 (questionaire for patients with brain neoplasm)
Time frame: time from randomisation until the date of death from any cause, assesd up to 24 month
changes in BN-20 scores, scale is 1-100 points, 100 points representing maximum score
10 secondary outcomes
functional independence assessed by the Barthel ADL index
Time frame: time from randomisation until the date of death from any cause, assesd up to 24 month
long-term cognitive Status (Hopkins Verbal Learning Test HVLT)
Time frame: time from randomisation until the date of death from any cause, assesd up to 24 month
development of radiation-induced brain lesions
Time frame: time from randomisation until the date of death from any cause, assesd up to 24 month
Radiation induced sideeffects
Time frame: time from randomisation until the date of death from any cause, assesd up to 24 month
Overall survival
Time frame: time from randomisation until the date of death from any cause, assesd up to 24 month
local progression of treated metastases
Time frame: time from randomisation until the date of death from any cause, assesd up to 24 month
intracranial progression of leptomeningeal disease
Time frame: time from randomisation until the date of death from any cause, assesd up to 24 month
intracranial progression of treated BM disease
Time frame: time from randomisation until the date of death from any cause, assesd up to 24 month
intracranial progression of new BM disease
Time frame: time from randomisation until the date of death from any cause, assesd up to 24 month
Brain salvage during follow-up
Time frame: time from randomisation until the date of death from any cause, assesd up to 24 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Juergen Debus, Prof. principal investigator
Head of Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SRS and Whole Brain Radiotherapy in people with Brain Metastases and Nsclc, run by University Hospital Heidelberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tanja Eichkorn, MD (06221 56 ext. 8201, tanja.eichkorn@med.uni-heidelbeg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: time from randomisation until the date of death from any cause, assesd up to 24 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.