D2 Resection and HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) in Locally Advanced Gastric Carcinoma
Conditions
Gastric Adenocarcinoma
Conditions: official terms
Adenocarcinoma - Stomach Neoplasms
Conditions: Keywords
Gastric adenocarcinoma, HIPEC, Oxaliplatin, Signet ring cell
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) with oxaliplatin Type: Drug
Name: Curative gastrectomy Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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
Locations
Service de Chirurgie Digestive Oncologique, CLCC Paul Papin
Angers, France
Status: Recruiting
Service de Chirurgie Digestive, Hôpital Jean Minjoz, CHU Besançon
Besançon, France
Status: Recruiting
Service de Chirurgie Viscérale, CLCC François Baclesse
Caen, France
Status: Recruiting
Service de Chirurgie Viscérale, CHU Estaing
Clermont-Ferrand, France
Status: Recruiting
Service de Chirurgie Générale et Digestive, Hôpital Louis Mourier
Colombes, France
Status: Recruiting
Service de Chirurgie Digestive, Hôpital du Bocage
Dijon, France
Status: Recruiting
Service de Chirurgie Digestive et de l'Urgence, Hôpital Michallon
Grenoble, France
Status: Recruiting
Service de Chirurgie Digestive et Générale, Hôpital Huriez
Lille, France
Status: Recruiting
Contact: Christophe MARIETTE, MD
Service de Chirurgie Digestive, CLCC Léon Bérard
Lyon, France
Status: Recruiting
Service d'Oncologie Digestive, Hôpital de la Timone
Marseille, France
Status: Recruiting
Contact: Jean-François SEITZ, MD
Service de Chirurgie Digestive, CRLC Val d'Aurelle
Montpellier, France
Status: Recruiting
Service de Chirurgie Digestive, CLCC René Gauducheau
Nantes, France
Status: Recruiting
Service de Chirurgie Digestive, Hôpital Archet II
Nice, France
Status: Recruiting
Service de Chirurgie Digestive, Hôpital Lariboisière
Paris, France
Status: Recruiting
Service de Chirurgie Digestive, Institut Curie
Paris, France
Status: Recruiting
Contact: Pascale MARIANI, MD
Service de Chirurgie Générale Digestive et Endocrinienne, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
Pierre Bénite, France
Status: Recruiting
Contact: Olivier GLEHEN, MD - 4 78 86 13 77 - olivier.glehen@chu-lyon.fr
Service de Chirurgie Viscérale, CHU de Poitiers
Poitiers, France
Status: Recruiting
Contact: Michel CARRETIER, MD
Service de Chirurgie Générale et Viscérale, CHU de Reims - Hôpital Robert Debré
Reims, France
Status: Recruiting
Contact: Reza KIANMANESH, MD
Service de Chirurgie Digestive et de Physiologie Digestive, Hôpital Ch. Nicolle
Rouen, France
Status: Recruiting
Service de Chirurgie Digestive, Hôpital Nord
Saint-Etienne, France
Status: Recruiting
Service de Chirurgie Viscérale et Digestive, Hôpital de Hautepierre
Strasbourg, France
Status: Recruiting
Service de Chirurgie Générale et Digestive, Hôpital Purpan
Toulouse, France
Status: Recruiting
Service de Chirurgie Digestive Oncologique, CLCC Alexis Vautrin
Vandoeuvre lès Nancy, France
Status: Recruiting
Département de Chirurgie Digestive et Hépatobiliaire, Institut Gustave Roussy
Villejuif, France
Status: Recruiting
Start Date
May 2013
Completion Date
May 2021
Sponsors
Hospices Civils de Lyon
Source
Hospices Civils de Lyon
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page