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

Обзор

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.

Подробное описание

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.

Вмешательства

• Лучевая терапия SRS
  Stereotactic Radiotherapy (SRS)
• Лучевая терапия Whole Brain Radiotherapy
  Whole Brain Radiotherapy (WBRT)

Первичные конечные точки

• overall survival [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: time from randomisation until the date of death from any cause, assesd up to 24 month]

Вторичные конечные точки (10)

• functional independence assessed by the Barthel ADL index [Срок оценки: 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) [Срок оценки: time from randomisation until the date of death from any cause, assesd up to 24 month]
• development of radiation-induced brain lesions [Срок оценки: time from randomisation until the date of death from any cause, assesd up to 24 month]
• Radiation induced sideeffects [Срок оценки: time from randomisation until the date of death from any cause, assesd up to 24 month]
• Overall survival [Срок оценки: time from randomisation until the date of death from any cause, assesd up to 24 month]
• local progression of treated metastases [Срок оценки: time from randomisation until the date of death from any cause, assesd up to 24 month]
• intracranial progression of leptomeningeal disease [Срок оценки: time from randomisation until the date of death from any cause, assesd up to 24 month]
• intracranial progression of treated BM disease [Срок оценки: time from randomisation until the date of death from any cause, assesd up to 24 month]
• intracranial progression of new BM disease [Срок оценки: time from randomisation until the date of death from any cause, assesd up to 24 month]
• Brain salvage during follow-up [Срок оценки: time from randomisation until the date of death from any cause, assesd up to 24 month]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Германия · 1 центр

• University Hospital of Heidelberg, Radiation Oncology — Heidelberg

Идентификаторы

NCT: NCT05378633 · The CyberChallenge Trial

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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