Clinical trial NCT01882933: D2 Resection and HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) in Locally Advanced Gastric Carcinoma
Official title: GASTRICHIP : D2 Resection and HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) in Locally Advanced Gastric Carcinoma. A Randomized and Multicentric Phase III Study.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Gastric Adenocarcinoma
Keywords: Gastric adenocarcinoma
HIPEC
Oxaliplatin
Signet ring cell
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2013-06-21
Enrollment: 367
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Overall survival
timeFrame: 5 years
Secondary outcomes:
measure: Recurrence-free survival
timeFrame: 5 years
measure: Recurrence-free survival
timeFrame: 3 years
measure: Locoregional-free survival
timeFrame: 5 years
measure: Treatment-related morbidity
timeFrame: During the 60th postoperative days
measure: Treatment-related mortality
timeFrame: During the 60th postoperative days
measure: Score QLQ-C30
timeFrame: 3 months (M3), 6 months (M6) and 12 months (M12) after surgery +/- HIPEC procedure.
measure: Score QLQ-STO 22
timeFrame: 3 months (M3), 6 months (M6) and 12 months (M12) after surgery +/- HIPEC procedure.
Other outcomes:
Locations:
city: Amiens
country: France
facility: Département de Chirurgie Digestive, CHU d'Amiens
city: Angers
country: France
facility: Service de Chirurgie Digestive Oncologique, CLCC Paul Papin
city: Angers
country: France
facility: Département de Chirurgie Digestive - CHU d'Angers
city: Besançon
country: France
facility: Service de Chirurgie Digestive, Hôpital Jean Minjoz, CHU Besançon
city: Caen
country: France
facility: Service de Chirurgie Viscérale, CLCC François Baclesse
city: Clermont-Ferrand
country: France
facility: Service de Chirurgie Viscérale, CHU Estaing
city: Dijon
country: France
facility: Service de Chirurgie Digestive, Hôpital du Bocage
city: Grenoble
country: France
facility: Service de Chirurgie Digestive et de l'Urgence, Hôpital Michallon
city: Lille
country: France
facility: Service de Chirurgie Digestive et Générale, Hôpital Huriez
city: Lyon
country: France
facility: Service de Chirurgie Digestive, CLCC Léon Bérard
city: Marseille
country: France
facility: Service d'Oncologie Digestive, Hôpital de la Timone
city: Montpellier
country: France
facility: Service de Chirurgie Digestive, CRLC Val d'Aurelle
city: Nantes
country: France
facility: Service de Chirurgie Digestive, CLCC René Gauducheau
city: Nice
country: France
facility: Service de Chirurgie Digestive, Hôpital Archet II
city: Paris
country: France
facility: Service de Chirurgie Digestive, Institut Curie
city: Paris
country: France
facility: Service de Chirurgie Viscérale et Oncologique, Hôpital Saint-Louis
city: Paris
country: France
facility: Service de Chirurgie Générale et Digestive, Hôpital Saint-Antoine, APHP
city: Paris
country: France
facility: Service de Chirurgie Digestive, Hôpital Lariboisière
city: Pierre Bénite
country: France
facility: Service de Chirurgie Générale Digestive et Endocrinienne, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
city: Poitiers
country: France
facility: Service de Chirurgie Viscérale, CHU de Poitiers
city: Reims
country: France
facility: Service de Chirurgie Générale et Viscérale, CHU de Reims - Hôpital Robert Debré
city: Rouen
country: France
facility: Service de Chirurgie Digestive et de Physiologie Digestive, Hôpital Ch. Nicolle
city: Saint-Etienne
country: France
facility: Service de Chirurgie Digestive, Hôpital Nord
city: Strasbourg
country: France
facility: Service de Chirurgie Viscérale et Digestive, Hôpital de Hautepierre
city: Toulouse
country: France
facility: Service de Chirurgie Générale et Digestive, Hôpital Purpan
city: Vandoeuvre lès Nancy
country: France
facility: Service de Chirurgie Digestive Oncologique, CLCC Alexis Vautrin
city: Villejuif
country: France
facility: Département de Chirurgie Digestive et Hépatobiliaire, Institut Gustave Roussy
city: Alcalá de Henares
country: Spain
facility: Hospital Universitario Principe de Asturias
city: Barcelona
country: Spain
facility: Hospital Sant Joan Despí Moises Broggi
city: Madrid
country: Spain
facility: Md Anderson Cancer Center
city: Madrid
country: Spain
facility: Fundación Jiménez Díaz Hospital
city: Madrid
country: Spain
facility: Hospital Universitario de La Paz
city: Madrid
country: Spain
facility: Hospital Universitario de Fuenlabrada
Study officials:
affiliation: Service de Chirurgie Générale Digestive et Endocrinienne, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
name: Olivier GLEHEN, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Glehen O, Passot G, Villeneuve L, Vaudoyer D, Bin-Dorel S, Boschetti G, Piaton E, Garofalo A. GASTRICHIP: D2 resection and hyperthermic intraperitoneal chemotherapy in locally advanced gastric carcinoma: a randomized and multicenter phase III study. BMC Cancer. 2014 Mar 14;14:183. doi: 10.1186/1471-2407-14-183.