Local Treatment Strategies for Brain Metastases of Colorectal Cancer: An International Observational Multicenter Retrospective Cohort Study (COLBRAIN)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 700
- 试验地点
- 15
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
COLBRAIN trial is an international (2 countries) observational, multicenter (15 centers) retrospective cohort study designed to investigate local treatment strategies for brain metastases of colorectal cancer.
详细描述
Brain metastases (BM) from colorectal cancer (CRC) are a rare event, reported in less than 3% of patients with CRC. This course is associated with a dismal prognosis, and treatment of these patients remains challenging. The rarity of the event complicates research into both the effectiveness of local treatment methods and long-term oncological outcomes. Published studies are largely limited to single-center series with non-representative small patient cohorts, making it difficult to assess the reasons for such unsatisfactory treatment results.
Despite its rarity, there is growing evidence that the incidence of BM from CRC is increasing. Although direct epidemiological data are limited, many experts believe the detection rate has risen over the past quarter-century. This trend is likely multifactorial, attributed to advances in neuroimaging techniques and improved life expectancy due to the evolution of systemic therapy strategies.
However, this increase in detection has not translated into improved outcomes. Central nervous system (CNS) involvement in CRC remains associated with a dismal prognosis; median overall survival from the time of progression ranges from 2 to 5 months and has not substantially improved over recent decades. The aggressive disease course and the unmet clinical need for effective therapeutic strategies highlight the importance of large-scale, real-world data.
The primary objective of this study is to evaluate, in a large multi-institutional real-world cohort, the effectiveness of the following local treatment modalities for CRC BM:
- Neurosurgical resection (NRS):
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Male and female patients aged 18 years or older;
- •Histologically confirmed epithelial malignancy of the colon or rectum (colorectal adenocarcinoma). Patients with synchronous or metachronous multiple primary tumors within the colon or rectum are eligible;
- •Radiologically ± histologically confirmed brain metastases, including:
- •Solid brain parenchymal metastases
- •Leptomeningeal disease (LMD)
- •Both solid metastases and LMD
排除标准
- •Synchronous or metachronous multiple primary malignancies (MPM) involving sites other than the colon or rectum
- •Primary tumor located outside the gastrointestinal tract;
- •Histologically confirmed non-epithelial gastrointestinal malignancy (e.g., neuroendocrine tumors, sarcoma, gastrointestinal stromal tumor, lymphoma);
- •Isolated spinal cord involvement without brain parenchymal metastases;
- •Incomplete medical records precluding assessment of at least one primary endpoint (OS, TTIP, or CNS-PFS). Patients with available data for any primary endpoint are eligible, even if other clinical details are missing.
- •Prior local treatment for brain metastases at an outside institution with no available records, precluding determination of the first local treatment modality
研究组 & 干预措施
Eligible Patients
Adult patients (≥ 18 years) with histologically confirmed colorectal adenocarcinoma and radiologically ± histologically documented brain metastases
干预措施: Neurosurgical Resection (NRS): En-bloc (EBR), Total piecemeal (TPR), Subtotal (SPR) or Partial (PPR) (Procedure)
Eligible Patients
Adult patients (≥ 18 years) with histologically confirmed colorectal adenocarcinoma and radiologically ± histologically documented brain metastases
干预措施: Radiotherapy (RT): Stereotactic Radiosurgery/Radiotherapy (SRS/SRT), Whole-Brain Radiotherapy (WBRT) (Radiation)
Eligible Patients
Adult patients (≥ 18 years) with histologically confirmed colorectal adenocarcinoma and radiologically ± histologically documented brain metastases
干预措施: Combined Local Treatment Modalities (Other)
Eligible Patients
Adult patients (≥ 18 years) with histologically confirmed colorectal adenocarcinoma and radiologically ± histologically documented brain metastases
干预措施: No Local Treatment (Other)
结局指标
主要结局
Overall Survival (OS)
时间窗: From date of brain metastasis diagnosis until death or last contact, assessed up to 5 years (censored)
Time from the date of brain metastasis diagnosis to the date of death from any cause or last follow-up (censored)
Time to Intracranial Progression (TTIP)
时间窗: From date of initial cancer diagnosis until first brain metastasis detection, assessed up to 10 years
Time from the date of initial colorectal cancer diagnosis to the date of first brain metastasis detection. Based on this interval, patients will be categorized as synchronous (≤ 60 days from primary diagnosis) or metachronous (\> 60 days).
Central Nervous System Progression-Free Survival (CNS-PFS)
时间窗: From the date of first local treatment for BM until subsequent intracranial progression or last imaging follow-up, assessed up to 5 years (censored)
Time from the date of first local treatment for brain metastases to the date of subsequent intracranial progression or last instrumental follow-up (censored). Intracranial progression includes: continued growth of treated lesion (≤ 6 months after treatment), local recurrence of treated lesion (\> 6 months after treatment), or development of new intracranial lesions.
次要结局
- Overall Survival from Initial Diagnosis(From date of initial cancer diagnosis until death or last contact, assessed up to 5 years)
- Cancer-Specific Survival(From date of brain metastasis diagnosis until death or last contact, assessed up to 5 years)
- Cumulative Incidence of Death from Intracranial Progression(From date of brain metastasis diagnosis until death or last contact, assessed up to 5 years)
- Cumulative Incidence of Death from Extracranial Progression(From date of brain metastasis diagnosis until death or last contact, assessed up to 5 years)
- Cumulative Incidence of Death from Non-cancer Causes(From date of brain metastasis diagnosis until death or last contact, assessed up to 5 years)
- Cumulative Incidence of Repeat Local Interventions(From date of first local treatment until the date of second local intervention or last follow-up, assessed up to 5 years (censored))
研究者
David Khalafyan
Principal Investigator, MD
Blokhin's Russian Cancer Research Center