The CyberChallenge Trial How Much is Too Much - What is the Role of Cyberknife Radiosurgery in Patients With Multiple Brain Metastases?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- quality of life according to BN-20 (questionaire for patients with brain neoplasm)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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)
研究组 & 干预措施
Experimental Treatment Arm
Best Supportive Care + Stereotactic Radiotherapy of all Brain Metastases
干预措施: SRS (Radiation)
Standard Treatment Arm
Best Supportive Care ± Whole Brain Radiotherapy
干预措施: Whole Brain Radiotherapy (Radiation)
结局指标
主要结局
quality of life according to BN-20 (questionaire for patients with brain neoplasm)
时间窗: 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
overall survival
时间窗: time from randomisation until the date of death from any cause, assesd up to 24 month
number of alive patients
quality of life according to QLQ-C15 (questionaire for patients with advanced cancer referred for palliative radiotherapy
时间窗: 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
次要结局
- intracranial progression of treated BM disease(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)
- intracranial progression of leptomeningeal disease(time from randomisation until the date of death from any cause, assesd up to 24 month)
- functional independence assessed by the Barthel ADL index(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)
- Brain salvage during follow-up(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)
- local progression of treated metastases(time from randomisation until the date of death from any cause, assesd up to 24 month)
- intracranial progression of new BM disease(time from randomisation until the date of death from any cause, assesd up to 24 month)
研究者
Juergen Debus
Head of Department
University Hospital Heidelberg