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

Primary Purpose

Gastric Adenocarcinoma

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) with oxaliplatin
Curative gastrectomy
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Adenocarcinoma focused on measuring Gastric adenocarcinoma, HIPEC, Oxaliplatin, Signet ring cell

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Département de Chirurgie Digestive, CHU d'Amiens
  • Service de Chirurgie Digestive Oncologique, CLCC Paul Papin
  • Département de Chirurgie Digestive - CHU d'Angers
  • Service de Chirurgie Digestive, Hôpital Jean Minjoz, CHU Besançon
  • Service de Chirurgie Viscérale, CLCC François Baclesse
  • Service de Chirurgie Viscérale, CHU Estaing
  • Service de Chirurgie Digestive, Hôpital du Bocage
  • Service de Chirurgie Digestive et de l'Urgence, Hôpital Michallon
  • Service de Chirurgie Digestive et Générale, Hôpital Huriez
  • Service de Chirurgie Digestive, CLCC Léon Bérard
  • Service d'Oncologie Digestive, Hôpital de la Timone
  • Service de Chirurgie Digestive, CRLC Val d'Aurelle
  • Service de Chirurgie Digestive, CLCC René Gauducheau
  • Service de Chirurgie Digestive, Hôpital Archet II
  • Service de Chirurgie Digestive, Institut Curie
  • Service de Chirurgie Viscérale et Oncologique, Hôpital Saint-Louis
  • Service de Chirurgie Générale et Digestive, Hôpital Saint-Antoine, APHP
  • Service de Chirurgie Digestive, Hôpital Lariboisière
  • Service de Chirurgie Générale Digestive et Endocrinienne, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
  • Service de Chirurgie Viscérale, CHU de Poitiers
  • Service de Chirurgie Générale et Viscérale, CHU de Reims - Hôpital Robert Debré
  • Service de Chirurgie Digestive et de Physiologie Digestive, Hôpital Ch. Nicolle
  • Service de Chirurgie Digestive, Hôpital Nord
  • Service de Chirurgie Viscérale et Digestive, Hôpital de Hautepierre
  • Service de Chirurgie Générale et Digestive, Hôpital Purpan
  • Service de Chirurgie Digestive Oncologique, CLCC Alexis Vautrin
  • Département de Chirurgie Digestive et Hépatobiliaire, Institut Gustave Roussy
  • Hospital Universitario Principe de Asturias
  • Hospital Sant Joan Despí Moises Broggi
  • Md Anderson Cancer Center
  • Fundación Jiménez Díaz Hospital
  • Hospital Universitario de La Paz
  • Hospital Universitario de Fuenlabrada

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Curative Gastrectomy + HIPEC

Curative Gastrectomy

Arm Description

Curative gastrectomy with D1-D2 lymph node dissection + HIPEC with oxaliplatin

Curative gastrectomy with D1-D2 lymph node dissection

Outcomes

Primary Outcome Measures

Overall survival
From the date of surgery to the date of death or to the end of follow-up

Secondary Outcome Measures

Recurrence-free survival
From the date of surgery to the date of recurrence or to the end of follow-up
Recurrence-free survival
From the date of surgery to the date of recurrence or to the end of follow-up
Locoregional-free survival
From the date of surgery to the date of locoregional recurrence or to the end of follow-up
Treatment-related morbidity
Common Terminology Criteria for Adverse Events v4.0
Treatment-related mortality
Score QLQ-C30
Quality of life is assessed with EORTC questionnaire QLQ-C30
Score QLQ-STO 22
Quality of life is assessed with EORTC questionnaire QLQ-STO 22

Full Information

First Posted
June 13, 2013
Last Updated
April 18, 2023
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT01882933
Brief Title
D2 Resection and HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) in Locally Advanced Gastric Carcinoma
Acronym
GASTRICHIP
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2013 (Actual)
Primary Completion Date
May 2026 (Anticipated)
Study Completion Date
May 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Adenocarcinoma
Keywords
Gastric adenocarcinoma, HIPEC, Oxaliplatin, Signet ring cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
367 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Curative Gastrectomy + HIPEC
Arm Type
Experimental
Arm Description
Curative gastrectomy with D1-D2 lymph node dissection + HIPEC with oxaliplatin
Arm Title
Curative Gastrectomy
Arm Type
Other
Arm Description
Curative gastrectomy with D1-D2 lymph node dissection
Intervention Type
Drug
Intervention Name(s)
HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) with oxaliplatin
Intervention Description
After the D2 resection is complete HIPEC can start. A roller pump forces the chemotherapy solution (oxaliplatin 250 mg/m² with 2 Liters of G5%/m²) into the abdomen through the inflow catheter and pulls it out through the drains. A heat exchanger keeps the intraperitoneal fluid at 42°-43°C.
Intervention Type
Procedure
Intervention Name(s)
Curative gastrectomy
Intervention Description
All the patients will undergo a D1-D2 gastrectomy carried out according to Japanese guidelines and to the European recommendations for the preservation of spleen and pancreas
Primary Outcome Measure Information:
Title
Overall survival
Description
From the date of surgery to the date of death or to the end of follow-up
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Recurrence-free survival
Description
From the date of surgery to the date of recurrence or to the end of follow-up
Time Frame
5 years
Title
Recurrence-free survival
Description
From the date of surgery to the date of recurrence or to the end of follow-up
Time Frame
3 years
Title
Locoregional-free survival
Description
From the date of surgery to the date of locoregional recurrence or to the end of follow-up
Time Frame
5 years
Title
Treatment-related morbidity
Description
Common Terminology Criteria for Adverse Events v4.0
Time Frame
During the 60th postoperative days
Title
Treatment-related mortality
Time Frame
During the 60th postoperative days
Title
Score QLQ-C30
Description
Quality of life is assessed with EORTC questionnaire QLQ-C30
Time Frame
3 months (M3), 6 months (M6) and 12 months (M12) after surgery +/- HIPEC procedure.
Title
Score QLQ-STO 22
Description
Quality of life is assessed with EORTC questionnaire QLQ-STO 22
Time Frame
3 months (M3), 6 months (M6) and 12 months (M12) after surgery +/- HIPEC procedure.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier GLEHEN, MD
Organizational Affiliation
Service de Chirurgie Générale Digestive et Endocrinienne, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Département de Chirurgie Digestive, CHU d'Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
Service de Chirurgie Digestive Oncologique, CLCC Paul Papin
City
Angers
ZIP/Postal Code
49033
Country
France
Facility Name
Département de Chirurgie Digestive - CHU d'Angers
City
Angers
ZIP/Postal Code
49100
Country
France
Facility Name
Service de Chirurgie Digestive, Hôpital Jean Minjoz, CHU Besançon
City
Besançon
ZIP/Postal Code
25030
Country
France
Facility Name
Service de Chirurgie Viscérale, CLCC François Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Service de Chirurgie Viscérale, CHU Estaing
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Service de Chirurgie Digestive, Hôpital du Bocage
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Service de Chirurgie Digestive et de l'Urgence, Hôpital Michallon
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Service de Chirurgie Digestive et Générale, Hôpital Huriez
City
Lille
ZIP/Postal Code
59067
Country
France
Facility Name
Service de Chirurgie Digestive, CLCC Léon Bérard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Service d'Oncologie Digestive, Hôpital de la Timone
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
Service de Chirurgie Digestive, CRLC Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Service de Chirurgie Digestive, CLCC René Gauducheau
City
Nantes
ZIP/Postal Code
44805
Country
France
Facility Name
Service de Chirurgie Digestive, Hôpital Archet II
City
Nice
ZIP/Postal Code
06200
Country
France
Facility Name
Service de Chirurgie Digestive, Institut Curie
City
Paris
ZIP/Postal Code
75005
Country
France
Facility Name
Service de Chirurgie Viscérale et Oncologique, Hôpital Saint-Louis
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Service de Chirurgie Générale et Digestive, Hôpital Saint-Antoine, APHP
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Service de Chirurgie Digestive, Hôpital Lariboisière
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Service de Chirurgie Générale Digestive et Endocrinienne, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
City
Pierre Bénite
ZIP/Postal Code
69495
Country
France
Facility Name
Service de Chirurgie Viscérale, CHU de Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Service de Chirurgie Générale et Viscérale, CHU de Reims - Hôpital Robert Debré
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
Service de Chirurgie Digestive et de Physiologie Digestive, Hôpital Ch. Nicolle
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Service de Chirurgie Digestive, Hôpital Nord
City
Saint-Etienne
ZIP/Postal Code
42055
Country
France
Facility Name
Service de Chirurgie Viscérale et Digestive, Hôpital de Hautepierre
City
Strasbourg
ZIP/Postal Code
67200
Country
France
Facility Name
Service de Chirurgie Générale et Digestive, Hôpital Purpan
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Service de Chirurgie Digestive Oncologique, CLCC Alexis Vautrin
City
Vandoeuvre lès Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Département de Chirurgie Digestive et Hépatobiliaire, Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Hospital Universitario Principe de Asturias
City
Alcalá de Henares
ZIP/Postal Code
28805
Country
Spain
Facility Name
Hospital Sant Joan Despí Moises Broggi
City
Barcelona
ZIP/Postal Code
08970
Country
Spain
Facility Name
Md Anderson Cancer Center
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
Fundación Jiménez Díaz Hospital
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario de La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario de Fuenlabrada
City
Madrid
ZIP/Postal Code
28942
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
24628950
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.
Results Reference
derived

Learn more about this trial

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

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