Local Treatment Strategies for Brain Metastases of Gastric and Esophageal Cancer: An International Observational Multicenter Retrospective Cohort Study (GASTROBRAIN)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 230
- 试验地点
- 15
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
GASTROBRAIN trial is an international (2 countries) observational, multicenter (15 centers) retrospective cohort study designed to investigate local treatment strategies for brain metastases of gastric and esophageal cancer
详细描述
Brain metastases (BM) arising from gastric cancer (GC) and esophageal cancer (EC) represent a rare but devastating complication of upper gastrointestinal malignancies. Historical estimates have placed the incidence of BM in this population at well below 1%, with some of the earliest large series reporting figures as low as 0.16% to 0.7%. This rarity, however, belies the clinical significance of the problem. Despite advances in systemic therapy, the prognosis for these patients has remained stubbornly poor, with median overall survival still measured in months.
The paucity of data directly resulting from this low incidence has created a critical knowledge gap. The current evidence base is fragmented, consisting predominantly of small, single-center case series. These studies are inherently limited by selection bias and lack the statistical power to draw definitive conclusions about the optimal sequencing and comparative effectiveness of various local treatment modalities.
This lack of high-level evidence has direct clinical consequences. Treatment decisions for patients with BM from GC and EC are frequently extrapolated from data on other solid tumors, such as lung or breast cancer, or are based on institutional preference and physician experience. This uncertainty underscores a profound unmet clinical need for large-scale, real-world data.
Investigators from a multi-institutional international consortium of cancer centers have therefore initiated a collaborative effort to create the largest and most comprehensive dataset of patients with gastric and esophageal cancer brain metastases described to date. Pooling clinical, pathological, molecular, and treatment-related data from patients diagnosed over the past quarter-century (2000-2025), this dataset will enable a robust analysis of modern local treatment patterns, long-term oncological outcomes, and prognostic factors - ultimately seeking to provide evidence-based insights to guide clinical decision-making for this rare and challenging patient population.
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 gastric and esophageal cancer brain metastases:
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 stomach (gastric adenocarcinoma), esophagus (esophageal adenocarcinoma), or gastroesophageal junction (GEJ adenocarcinoma). Patients with squamous cell carcinoma of the esophagus are also 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 stomach, esophagus, or gastroesophageal junction;
- •Primary tumor located outside the stomach, esophagus, or gastroesophageal junction;
- •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 adenocarcinoma of the stomach, adenocarcinoma or squamous cell carcinoma of the esophagus, or adenocarcinoma of the gastroesophageal junction, 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 adenocarcinoma of the stomach, adenocarcinoma or squamous cell carcinoma of the esophagus, or adenocarcinoma of the gastroesophageal junction, 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 adenocarcinoma of the stomach, adenocarcinoma or squamous cell carcinoma of the esophagus, or adenocarcinoma of the gastroesophageal junction, and radiologically ± histologically documented brain metastases.
干预措施: Combined Local Treatment Modalities (Other)
Eligible Patients
Adult patients (≥ 18 years) with histologically confirmed adenocarcinoma of the stomach, adenocarcinoma or squamous cell carcinoma of the esophagus, or adenocarcinoma of the gastroesophageal junction, 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 gastric and esophageal cancer diagnosis to the date of first BM 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)
研究者
David Khalafyan
Principal Investigator
Blokhin's Russian Cancer Research Center