2026-526209-13-00招募中1 期
A more sustainable perioperative treatment regimen for gastroesophageal cancer —replacing 5-FU with capecitabine within the FLOT regimen
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2026年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- The MTD will be established using a 3+3 dose escalation design in which the amount of DLTs will determine the MTD (see 6.1 Trial design for a detailed explanation)
研究概览
简要总结
To determine the MTD and recommended dose of perioperative Capecitabine within the DOC regimen in oesophageal, GEJ and gastric adenocarcinoma patients
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed esophageal, GEJ, or gastric cancer with an indication for perioperative FLOT chemotherapy
- •WHO-performance score of 0 to 1
- •Aged 18 years or older
- •Written informed consent according to the ICH-GCP and national/local regulations
排除标准
- •All routinely tested DPYD variants
- •Any contra-indication for the (planned) FLOT regimen (e.g. active infection, serious concomitant disease, severe allergy, neurologic toxicity), as determined by the treating medical oncologist
- •Inadequate organ functions (defined as a hemoglobin <5.0 mmol/L (before transfusion), an absolute neutrophil count <1.5 x 109/l, platelet count <100 x 109/l, creatinine clearance <30 mL/min, bilirubin >2x ULN and liver transaminases >2.5x ULN)
- •Pregnant or lactating women
- •Concomitant participation in any clinical study that could modify the outcomes relevant to this study
- •Unwillingness or inability to comply with the study protocol
- •Inability to take capecitabine tablets due to swallowing difficulties (i.e. dysphagia grade 3 or higher)
- •Inability to receive a full dose of capecitabine/5-FU (e.g. due to impaired renal function or other clinically relevant contraindications or treatment-related toxicity)
结局指标
主要结局
The MTD will be established using a 3+3 dose escalation design in which the amount of DLTs will determine the MTD (see 6.1 Trial design for a detailed explanation)
The MTD will be established using a 3+3 dose escalation design in which the amount of DLTs will determine the MTD (see 6.1 Trial design for a detailed explanation)
次要结局
- Assessed by analyzing the AUCs of capecitabine metabolites and comparing them within each patient between the preoperative and postoperative settings. These AUC values will subsequently be used to calculate an AUC ratio
- Percentage of patients discontinuing treatment due to treatment-related adverse events, Percentage of patients completing neoadjuvant treatment cycles, Percentage of patients completing adjuvant treatment cycles
- Safety of the administered treatment, assessed by: - All treatment-related adverse events (AEs) according to CTCAEv6 - All serious adverse events (SAEs); - All postoperative complications Additionally, AEs preoperatively will be compared to AEs postoperatively.
研究者
Bianca Mostert
Scientific
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
研究点 (1)
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