D2 Resection and HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) in Locally Advanced Gastric Carcinoma
- Conditions
- Gastric Adenocarcinoma
- Interventions
- Drug: HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) with oxaliplatinProcedure: Curative gastrectomy
- Registration Number
- NCT01882933
- Lead Sponsor
- Hospices Civils de Lyon
- Brief Summary
A prospective, opened, multicentric, randomised, phase III trial with two arms:
* Arm A: curative gastrectomy with D1-D2 lymph node dissection + HIPEC with oxaliplatin
* Arm B: curative gastrectomy with D1-D2 lymph node dissection
Main objective: Compare overall 5-year survival rates in patients surgically treated for advanced gastric adenocarcinoma (T3, T4 and/or N+ and/or with positive peritoneal cytology), treated either with curative gastrectomy and adjuvant HIPEC, or with curative gastrectomy alone.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 367
- 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.
- Prior malignant tumors with detectable signs of recurrence
- Gastric stump adenocarcinoma
- Presence of comorbidities, notably serious chronic diseases or organ failure General conditions
- Any subject in exclusion period of a previous study according to applicable regulations
- 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 Interfering substance
- Contraindication to any drug contained in the chemotherapy regimen Specific to the study
- Life threatening toxicity before surgery
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Curative Gastrectomy + HIPEC HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) with oxaliplatin Curative gastrectomy with D1-D2 lymph node dissection + HIPEC with oxaliplatin Curative Gastrectomy Curative gastrectomy Curative gastrectomy with D1-D2 lymph node dissection Curative Gastrectomy + HIPEC Curative gastrectomy Curative gastrectomy with D1-D2 lymph node dissection + HIPEC with oxaliplatin
- Primary Outcome Measures
Name Time Method Overall survival 5 years From the date of surgery to the date of death or to the end of follow-up
- Secondary Outcome Measures
Name Time Method Locoregional-free survival 5 years From the date of surgery to the date of locoregional recurrence or to the end of follow-up
Treatment-related morbidity During the 60th postoperative days Common Terminology Criteria for Adverse Events v4.0
Recurrence-free survival 3 years From the date of surgery to the date of recurrence or to the end of follow-up
Treatment-related mortality During the 60th postoperative days Score QLQ-C30 3 months (M3), 6 months (M6) and 12 months (M12) after surgery +/- HIPEC procedure. Quality of life is assessed with EORTC questionnaire QLQ-C30
Score QLQ-STO 22 3 months (M3), 6 months (M6) and 12 months (M12) after surgery +/- HIPEC procedure. Quality of life is assessed with EORTC questionnaire QLQ-STO 22
Trial Locations
- Locations (33)
Département de Chirurgie Digestive, CHU d'Amiens
🇫🇷Amiens, France
Service de Chirurgie Digestive Oncologique, CLCC Paul Papin
🇫🇷Angers, France
Département de Chirurgie Digestive - CHU d'Angers
🇫🇷Angers, France
Service de Chirurgie Digestive, Hôpital Jean Minjoz, CHU Besançon
🇫🇷Besançon, France
Service de Chirurgie Viscérale, CLCC François Baclesse
🇫🇷Caen, France
Service de Chirurgie Viscérale, CHU Estaing
🇫🇷Clermont-Ferrand, France
Service de Chirurgie Digestive, Hôpital du Bocage
🇫🇷Dijon, France
Service de Chirurgie Digestive et de l'Urgence, Hôpital Michallon
🇫🇷Grenoble, France
Service de Chirurgie Digestive et Générale, Hôpital Huriez
🇫🇷Lille, France
Service de Chirurgie Digestive, CLCC Léon Bérard
🇫🇷Lyon, France
Scroll for more (23 remaining)Département de Chirurgie Digestive, CHU d'Amiens🇫🇷Amiens, France