2024-516358-23-00招募中3 期
GASTRICHIP TRIAL. D2 resection and HIPEC (Hyperthermic IntraPeritoneal Chemoperfusion) in locally advanced gastric carcinoma. A randomized and multicentric phase III study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 367
- 试验地点
- 10
- 主要终点
- Overall survival
研究概览
简要总结
Compare overall 5-year survival rates in patients surgically treated for advanced gastric adenocarcinoma (T3, T4 and/or N+ and/or with positive cytology), treated either with curative gastrectomy and adjuvant Hyperthermic Intraperitoneal Chemotherapy (HIPEC) (Arm A), or with curative gastrectomy alone (Arm B).
研究设计
- 分配方式
- Randomized
- 主要目的
- Hipec (hyperthermic Intraperitoneal Chemoperfusion) With Oxaliplatin/curative Gastrectomy
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •18 < age ≤ 75 years old
- •Histologically evidenced resectable T3 or T4 for which a curative gastrectomy is scheduled, with invasion into the serosa AND/OR lymph node metastasis (determined from data obtained by endoscopic ultrasound and chest, abdomen and pelvis CT scan) AND/OR positive peritoneal cytology (sampled during the preoperative laparoscopy).
- •Females of childbearing age potential and male subjects with partners of childbearing potential using efficient contraceptive measures (as judged by the investigator).Subjects randomised in the arm with HIPEC should be informed and accept that these requirements should also extend to : * 4 months after the treatment with Oxaliplatin for female subjects, * 6 months after the treatment with Oxaliplatin for male subjects.
- •White blood cells > 3,500/mm3, neutrophils ≥ 1,500/mm3, platelets ≥ 100,000/mm3
- •Good renal functions, serum creatinine values being < 1.5 mg/dl and creatinine clearance > 60 ml/min
- •Performance Status ≤1, Karnofsky Index ≥ 70%
- •Serum bilirubin ≤ 2 mg/dl
- •Having given written informed consent prior to any procedure related to the study
- •Covered by a Health System where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research
- •Not under any administrative or legal supervision Specific to the study
- •Gastric adenocarcinoma and/or perforated gastric adenocarcinoma and/or Siewert III adenocarcinoma of the cardia
排除标准
- •Prior malignant tumors with detectable signs of recurrence
- •Pregnancy or breastfeeding
- •Females of childbearing age potential or male subjects with partners of childbearing potential not using medically accepted contraceptive measures, as judged by the investigator
- •Contraindication to any drug contained in the chemotherapy regimen - Life threatening toxicity before surgery
- •Distant metastases (liver, lung. ovaries, etc)
- •Life threatening toxicity before surgery
- •Tumoral infiltration of the head or body of the pancreas
- •Patients presenting an adenocarcinoma of the cardia Siewert I or II
- •Existence of macroscopic peritoneal implants
- •Patients with clinically significant ascites (> 500 cc) even if cytology is negative for cancer cells, in the absence of other non-malignant causes of ascites
- •Gastric stump adenocarcinoma
- •Presence of comorbidities, notably serious chronic diseases or organ failure (ASA > 3)
- •Peripheral neuropathy grade of ≥ 3 (CTC-AE V4.0) (if appropriate)
- •Any subject in exclusion period of a previous study according to applicable regulations
结局指标
主要结局
Overall survival
Overall survival
次要结局
- Recurrence-free survivals (peritoneal recurrence, locoregional recurrence, metastatic recurrence, site of recurrence )
- Treatment-related toxicity
- Treatment-related mortality
- Treatment related morbidity
- Quality of life
研究者
Pr Olivier GLEHEN
Scientific
Hospices Civils De Lyon
研究点 (10)
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