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

Nsclc Clinical Trial

— CyberChallenge  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05378633
• Other study ID #: The CyberChallenge Trial
• Status: Recruiting
• Phase: Phase 2
• Start date: February 24, 2022
• Est. completion date: February 24, 2026

Study information

• Verified date: January 2024
• Source: University Hospital Heidelberg
• Contact: Tanja Eichkorn, MD
• Phone: 06221 56
• Email: tanja.eichkorn[@]med.uni-heidelbeg.de
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: February 24, 2026
• Est. primary completion date: February 24, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Neoplasm Metastasis
• Nsclc

Intervention

Radiation:
• SRS
Stereotactic Radiotherapy (SRS)
• Whole Brain Radiotherapy
Whole Brain Radiotherapy (WBRT)

Locations

Country	Name	City	State
Germany	University Hospital of Heidelberg, Radiation Oncology	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Heidelberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival	number of alive patients	time from randomisation until the date of death from any cause, assesd up to 24 month
Primary	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
Primary	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	functional independence assessed by the Barthel ADL index	Changes in Barthel ADL index scores, scale 0-100 points	time from randomisation until the date of death from any cause, assesd up to 24 month
Secondary	long-term cognitive Status (Hopkins Verbal Learning Test HVLT)	Changes in HVLT scores (minimum 0, maximum 12)	time from randomisation until the date of death from any cause, assesd up to 24 month
Secondary	development of radiation-induced brain lesions	changes in amounts of Radiation-induced brain lesions	time from randomisation until the date of death from any cause, assesd up to 24 month
Secondary	Radiation induced sideeffects	changes in toxicity rates according to CTCAE 5.0	time from randomisation until the date of death from any cause, assesd up to 24 month
Secondary	Overall survival	amount of alive randomized patients enrolled in the trial	time from randomisation until the date of death from any cause, assesd up to 24 month
Secondary	local progression of treated metastases	detectable progressive disease of treated metastases	time from randomisation until the date of death from any cause, assesd up to 24 month
Secondary	intracranial progression of leptomeningeal disease	occurrence of leptomeningeal disease	time from randomisation until the date of death from any cause, assesd up to 24 month
Secondary	intracranial progression of treated BM disease	recurrence of treated BM disease	time from randomisation until the date of death from any cause, assesd up to 24 month
Secondary	intracranial progression of new BM disease	occurrence of new BM disease	time from randomisation until the date of death from any cause, assesd up to 24 month
Secondary	Brain salvage during follow-up	medical idication for whole brain Radiation after inital stereotactic radiotherapy	time from randomisation until the date of death from any cause, assesd up to 24 month