A Randomized, Multicenter Clinical Trial Comparing the Combination of Perioperative FLOT Chemotherapy and Preoperative Laparoscopic Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Plus Gastrectomy to Perioperative FLOT Chemotherapy and Gastrectomy Alone in Patients With Advanced Gastric Cancer at High Risk of Peritoneal Recurrence
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Peritoneal recurrence rate
研究概览
简要总结
The study was designed to evaluate the efficacy of perioperative FLOT chemotherapy in combination with perioperative hyperthermic intraperitoneal chemotherapy (HIPEC) in patients with advanced gastric cancer at high risk of peritoneal metastases. The impact of treatment on peritoneal recurrence and survival over 6 months, 1, 3 and 5 years will be assessed.
详细描述
This is a randomized, multicenter, clinical trial in which 598 patients with advanced gastric cancer at high risk of peritoneal metastases are randomly allocated to receive either preoperative hyperthermic intraperitoneal chemotherapy (HIPEC) plus gastrectomy (experimental group) or gastrectomy alone (control group). All patients, regardless of allocation, will additionally receive 4 cycles of FLOT chemotherapy (docetaxel 50 mg/m2, oxaliplatin 85 mg/m2, leucovorin 200 mg/m2 and 5-fluorouracil 2600 mg/m2) before surgery ± HIPEC and 4 cycles of FLOT chemotherapy after gastrectomy. The main outcome is frequency of peritoneal recurrence by 6-months post-operative. Patients will be followed for 5 years and undergo additional evaluations at 6 months, 1 year, 3 and 5 years.
The study will take place at 7 hospitals across Poland. All participating centers have the equipment and skills to perform all necessary procedures in this study. The below centers specialize in the treatment of stomach cancer with many documented years of experience. They are trained in the maintenance of a register, possess the skills to conduct appropriate research analyses and are equipped with a system for assessing the quality of both surgical and oncological treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gastric cancer confirmed histopathologically in tumor specimens.
- •Age 18-75 years.
- •Advanced gastric cancer cT3 / cT4a / N0-3b.
- •No distant metastases on computed tomography (CT) scan of the chest, abdomen and pelvis (cM0).
- •Written consent to participate in the study.
排除标准
- •No clear histopathological confirmation of gastric cancer.
- •Age > 75 years.
- •Poor general condition (Performance Status 3 or more on the Eastern Cooperative Oncology Group (ECOG)/World Health Organization scale).
- •Previous abdominal surgery (including oncological surgery), other than laparoscopic cholecystectomy or appendectomy (open or laparoscopic).
- •Pregnancy and lactation.
- •Refusal to participate or an inability to provide written consent.
- •Coexisting cancer in another location.
- •Systemic treatment or radiotherapy for another cancer.
- •Dysphagia requiring surgical treatment (gastric resection or nutritional jejunostomy) before starting neoadjuvant treatment and indication for accelerated surgery for other reasons.
- •Disqualification for perioperative FLOT4 chemotherapy as decided by a multi-specialist consultation.
结局指标
主要结局
Peritoneal recurrence rate
时间窗: 6 months
The rate of peritoneal recurrences at 6 month time from randomisation
次要结局
- Systemic recurrence rate(5 years)
- Treatment-related quality of life assessed by Quality Of Life Questionnaire (QLQ) C30 version 3.0(6 months)
- Local recurrence rate(5 years)
- Complications rate(6 months)
- Overall survival(5 years)
- Treatment-related quality of life assessed by Quality of Life Questionnaire-Stomach (STO22)(6 months)
研究者
Radoslaw Pach, MD, PhD
Principal Investigator
Jagiellonian University