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

NCT05378633 | Recruiting

• 1 other identifier: The CyberChallenge Trial
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Metastases; Nsclc

Keywords

Metastases; Cyberknife; Lung Cancer

Outcome Measures

Primary Outcomes (3)

• overall survival

  number of alive patients

  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

  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

  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

  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 from randomisation until the date of death from any cause, assesd up to 24 month

• development of radiation-induced brain lesions

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

• Radiation induced sideeffects

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

• Overall survival

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

Study Arms (2)

Experimental Treatment Arm

EXPERIMENTAL

Best Supportive Care + Stereotactic Radiotherapy of all Brain Metastases

Radiation: SRS

Standard Treatment Arm

OTHER

Best Supportive Care ± Whole Brain Radiotherapy

Radiation: Whole Brain Radiotherapy

Interventions

SRS RADIATION

Stereotactic Radiotherapy (SRS)

Experimental Treatment Arm

Whole Brain Radiotherapy RADIATION

Whole Brain Radiotherapy (WBRT)

Standard Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• histologically confirmed malignant illness
• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital Heidelberg: lead

Study Sites (1)

University Hospital of Heidelberg, Radiation Oncology

Heidelberg, 69120, Germany

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms; Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis; Lung Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Juergen Debus, Prof.

  Head of Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tanja Eichkorn, MD

CONTACT

06221 56; tanja.eichkorn@med.uni-heidelbeg.de

Adriane Hommertgen, Phd

CONTACT

06221 56; adriane.hommertgen@med.uni-heidelberg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: May 18, 2022
• Study Start: February 24, 2022
• Primary Completion (Estimated): February 24, 2027
• Study Completion (Estimated): February 24, 2028
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)