The Cohort for Patient-reported Outcomes, Imaging and Trial Inclusion in Metastatic BRAin Disease (COIMBRA)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- UMC Utrecht
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Survival
研究概览
简要总结
The incidence of brain metastases is expected to increase because of better treatments of primary tumours. Novel diagnostic and therapeutic techniques are continuously being developed, all of which need thorough evaluation before they can be implemented in clinical routine. Randomized Controlled Trials are the gold standard to do so, but they have shown many challenges, especially when applied in a cancer setting.
.The 'cohort multiple Randomized Controlled Trial (cmRCT)' design is a promising design for multiple (simultaneous) randomized evaluations of experimental interventions, with potential for increased recruitment, comparability and long-term outcomes as a standard. This design will speed up the process of translating treatment innovations to the daily clinic.
详细描述
The COIMBRA cohort is a prospective cohort, which will serve as a facility for efficient, systematic and simultaneous evaluation of new interventions and MRI sequences and prospective outcome studies (including prediction modelling).
COIMBRA patients will be followed prospectively and information on survival, symptoms, QoL (patient and caregiver), cognition, toxicity and daily functioning in relation to treatment will be collected prospectively.
Patients will receive the regular optimal clinical care according to the current guidelines when not participating in cmRCT's.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥ 18 years;
- •Either radiographic and/or histologic proof of metastatic brain disease, or eligible for prophylactic cranial irradiation;
- •Referred to the Department of Radiotherapy for cranial irradiation.
排除标准
- •Mental disorder or cognitive dysfunction that hinder the patient's ability to understand the informed consent procedure and/or study details;
- •Patients with severe psychiatric disorders;
- •Inability to understand the Dutch language.
结局指标
主要结局
Survival
时间窗: Through study completion, an average of 1 year
Survival of participating patients will be recorded using the follow up questionnaires (returned by family members) or are derived from the Municipal Personal Records Database (in Dutch: Basisregistratie Personen (BRP))
Time and Type of re-intervention
时间窗: Through study completion, an average of 1 year
Re-intervention (re-irradiation, surgery, other); Development of neurological symptoms; Development of new metastases.
Change in toxicity after radiotherapy
时间窗: Through study completion, an average of 1 year
The toxicity will be reported by using the serious adverse event (SAE) questionnaire, every 6 months
Technical and treatment data
时间窗: Through study completion, an average of 1 year
Dose, fractions and technique of radiotherapy. All other planned and/or received treatment for brain metastases and primary tumour (i.e. systemic therapy, surgery, radiotherapy), and the characteristics there of (type, dose, duration, awake surgery, extent of surgery, complications) - Use of epileptic drugs, including type and dose
次要结局
- Change in patient reported outcomes; general quality of life(Through study completion, an average of 1 year)
- Change in patient reported outcomes; cancer related fatigue(Through study completion, an average of 1 year)
- Caregiver coping and personality(Baseline)
- Neurocognitive functioning(We are testing this twice: once before radiotherapy and 3 months after radiotherapy)
- Change in patient reported outcomes; depression and anxiety(Through study completion, an average of 1 year)
- Change in patient reported outcomes; disease-specific symptoms of brain metastases and (adverse) effects of their treatment(Through study completion, an average of 1 year)
- Change in caregiver reported outcomes: general quality of life(Through study completion, an average of 1 year)
- Patients coping and personality(Baseline)
- Change in caregiver reported outcomes: depression and anxiety(Through study completion, an average of 1 year)
- Change in the caregiver burden(Through study completion, an average of 1 year)
研究者
Joost J.C. Verhoeff
Principal Investigator, Radiation Oncologist
UMC Utrecht