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NCT Number: NCT05378633

The CyberChallenge Trial How Much is Too Much - What is the Role of Cyberknife Radiosurgery in Patients With Multiple Brain Metastases?

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.

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Key information

Conditions

Brain Metastases Brain Diseases Brain Neoplasms Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Central Nervous System Diseases Central Nervous System Neoplasms Lung Diseases Lung Neoplasms NSCLC Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Nervous System Diseases Nervous System Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

SRS

Radiation

Stereotactic Radiotherapy (SRS)

whole brain radiotherapy

Radiation

Whole Brain Radiotherapy (WBRT)

Primary outcomes

  1. overall survival

    Time frame: time from randomisation until the date of death from any cause, assesd up to 24 month

    number of alive patients

  2. 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

  3. 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

Secondary outcomes

  1. 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

    Changes in Barthel ADL index scores, scale 0-100 points

  2. 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

    Changes in HVLT scores (minimum 0, maximum 12)

  3. development of radiation-induced brain lesions

    Time frame: time from randomisation until the date of death from any cause, assesd up to 24 month

    changes in amounts of Radiation-induced brain lesions

  4. Radiation induced sideeffects

    Time frame: time from randomisation until the date of death from any cause, assesd up to 24 month

    changes in toxicity rates according to CTCAE 5.0

  5. Overall survival

    Time frame: time from randomisation until the date of death from any cause, assesd up to 24 month

    amount of alive randomized patients enrolled in the trial

  6. local progression of treated metastases

    Time frame: time from randomisation until the date of death from any cause, assesd up to 24 month

    detectable progressive disease of treated metastases

  7. intracranial progression of leptomeningeal disease

    Time frame: time from randomisation until the date of death from any cause, assesd up to 24 month

    occurrence of leptomeningeal disease

  8. intracranial progression of treated BM disease

    Time frame: time from randomisation until the date of death from any cause, assesd up to 24 month

    recurrence of treated BM disease

  9. intracranial progression of new BM disease

    Time frame: time from randomisation until the date of death from any cause, assesd up to 24 month

    occurrence of new BM disease

  10. Brain salvage during follow-up

    Time frame: time from randomisation until the date of death from any cause, assesd up to 24 month

    medical idication for whole brain Radiation after inital stereotactic radiotherapy

Study contacts

Contact information is provided by the study sponsor or research team.

Adriane Hommertgen, Phd

CONTACT

[email protected]

06221 56 ext. 34091

Tanja Eichkorn, MD

CONTACT

[email protected]

06221 56 ext. 8201

Sponsors and collaborators

Lead sponsor

University Hospital Heidelberg

Other

Registry information

Acronym: CyberChallenge

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
May 18, 2022
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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