D2 Resection and HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) in Locally Advanced Gastric Carcinoma

Korábbi kezelés

• Any subject in exclusion period of a previous study according to applicable regulations
• Contraindication to any drug contained in the chemotherapy regimen Specific to the study
• Life threatening toxicity before surgery
• Existence of macroscopic peritoneal implants

Más betegség

• Prior malignant tumors with detectable signs of recurrence
• Presence of comorbidities, notably serious chronic diseases or organ failure General conditions
• 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

Életkor

• Females of childbearing age potential or male subjects with partners of childbearing potential not using medically accepted contraceptive measures, as judged by the investigator Interfering substance

Egyéb

• Gastric stump adenocarcinoma
• Pregnancy or breastfeeding
• Distant metastases (liver, lung. ovaries, etc)
• Tumoral infiltration of the head or body of the pancreas
• Patients presenting an adenocarcinoma of the cardia Siewert I or II

• 18 < age ≤ 75 years old
• 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
• Histologically evidenced resectable T3 or T4 gastric adenocarcinoma 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).
  • AND/OR
• Perforated gastric adenocarcinoma AND/OR
• Siewert III adenocarcinoma of the cardia for which a gastrectomy by exclusive abdominal laparotomy is scheduled
• 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.