Pilot Study on Feasibility and Safety of FLOT Regimen as Neoadjuvant Chemotherapy in Chinese Gastric Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Completion rate of preoperative FLOT regimen
研究概览
简要总结
Neoadjuvant chemotherapy for advanced-stage gastric cancer is justified by various studies, however, there was not any large scale randomized controlled trial (RCT) to support it until German oncologist introduced a novel regimen(FLOT regimen) in 2017. Investigator assessed the FLOT regimen for safety and feasibility in Chinese gastric cancer patients.
详细描述
Neoadjuvant chemotherapy for advanced-stage gastric cancer is justified by various studies, however, there was not any large scale RCT to support it until German oncologist introduced a novel regimen(FLOT regimen) in 2017. FLOT regimen was prescribed for German patients and various questions are raised by experts from Eastern countries. As the FLOT regimen was officially included in NCCN 2018 guidelines, the investigator used standard protocol of FLOT regimen on Chinese gastric cancer patients. Safety and feasibility were assessed carefully to provide basic data for further large scale studies in China.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histology confirmed adenocarcinoma of the stomach or esophagogastric junction.
- •Clinical stage: Clinical Tumor-Node-Metastasis (cTNM): stage III，IVa
- •Performance status: Eastern Cooperative Oncology Group ECOG 0- 2
- •Adequate renal, hepatic, hematologic, and pulmonary function.
- •Written informed consent
排除标准
- •Uncontrolled cardiac disease, or other clinically significant uncontrolled comorbidities
- •Distant metastases
- •Prior chemo or radiotherapy
- •Inclusion in another clinical trial
- •Known contraindications or hypersensitivity for planned chemotherapy
研究组 & 干预措施
Neoadjuvant chemotherapy
FLOT Chemotherapy regimen
A cycle consist of Day 1: 5-fluorouracil (5-FU) 2600mg/M2 intravenous Via peripherally inserted central catheter (PICC) for 24 hour Day 1: Leucovorin 200mg/M2 intravenous Day 1: Oxaliplatin 85mg/ M2 intravenous Day 1: Docetaxel 50mg/M2 intravenous Repeated every 15th day
干预措施: Chemotherapy (Drug)
结局指标
主要结局
Completion rate of preoperative FLOT regimen
时间窗: upto 3 months
How many patients completed the plan preoperative chemotherapy regimen
次要结局
- Pathological response rate(Upto three months)
- Adverse events(Upto three months)
- Postoperative morbidity(Upto one month after hospital discharge)
- Postoperative mortality(Upto one month after hospital discharge)