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

NCT ID: NCT05378633

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-24
• Study Completion Date: 2026-02-24

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental Treatment Arm

Best Supportive Care + Stereotactic Radiotherapy of all Brain Metastases

Group Type: EXPERIMENTAL

SRS

Intervention Type: RADIATION

Stereotactic Radiotherapy (SRS)

Standard Treatment Arm

Best Supportive Care ± Whole Brain Radiotherapy

Group Type: OTHER

Whole Brain Radiotherapy

Intervention Type: RADIATION

Whole Brain Radiotherapy (WBRT)

Interventions

SRS

Stereotactic Radiotherapy (SRS)

Intervention Type: RADIATION

Whole Brain Radiotherapy

Whole Brain Radiotherapy (WBRT)

Intervention Type: RADIATION

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Heidelberg

OTHER

Sponsor Role: lead

Responsible Party

Juergen Debus

Head of Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juergen Debus, Prof.

Role: PRINCIPAL_INVESTIGATOR

Head of Department

Locations

University Hospital of Heidelberg, Radiation Oncology

Heidelberg, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Tanja Eichkorn, MD

Role: CONTACT

tanja.eichkorn@med.uni-heidelbeg.de

06221 56 ext. 8201

Adriane Hommertgen, Phd

Role: CONTACT

adriane.hommertgen@med.uni-heidelberg.de

06221 56 ext. 34091

Facility Contacts

Jürgen Debus, Prof. Dr.

Role: primary

juergen.debus@med.uni-heidelberg.de

+49-6221-56 ext. 8202

Adriane Hommertgen

Role: backup

adriane.hommertgen@med.uni-heidelberg.de

+49-6221-56 ext. 34091

Other Identifiers

The CyberChallenge Trial

Identifier Type: -

Identifier Source: org_study_id