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

• ClinicalTrials.gov Identifier: NCT01882933
• Recruitment Status: Active, not recruiting
• First Posted: June 21, 2013
• Last Update Posted: April 19, 2023
• Sponsor: Hospices Civils de Lyon
• Information provided by (Responsible Party): Hospices Civils de Lyon

Tracking Information

• First Submitted Date: June 13, 2013
• First Posted Date: June 21, 2013
• Last Update Posted Date: April 19, 2023
• Actual Study Start Date: June 2013
• Estimated Primary Completion Date: May 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 20, 2013)

Overall survival [ Time Frame: 5 years ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 13, 2020)

• Recurrence-free survival [ Time Frame: 5 years ]
  From the date of surgery to the date of recurrence or to the end of follow-up
• Recurrence-free survival [ Time Frame: 3 years ]
  From the date of surgery to the date of recurrence or to the end of follow-up
• Locoregional-free survival [ Time Frame: 5 years ]
  From the date of surgery to the date of locoregional recurrence or to the end of follow-up
• Treatment-related morbidity [ Time Frame: During the 60th postoperative days ]
  Common Terminology Criteria for Adverse Events v4.0
• Treatment-related mortality [ Time Frame: During the 60th postoperative days ]
• Score QLQ-C30 [ Time Frame: 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 [ Time Frame: 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

Original Secondary Outcome Measures (submitted: June 20, 2013)

• Recurrence-free survival [ Time Frame: 5 years ]
  From the date of surgery to the date of recurrence or to the end of follow-up
• Recurrence-free survival [ Time Frame: 3 years ]
  From the date of surgery to the date of recurrence or to the end of follow-up
• Locoregional-free survival [ Time Frame: 5 years ]
  From the date of surgery to the date of locoregional recurrence or to the end of follow-up
• Treatment-related morbidity [ Time Frame: During the 60th postoperative days ]
  Common Terminology Criteria for Adverse Events v4.0
• Treatment-related mortality [ Time Frame: During the 60th postoperative days ]
• Quality of life [ Time Frame: 3 months (M3), 6 months (M6) and 12 months (M12) after surgery +/- HIPEC procedure. ]
  EORTC questionnaires QLQ-C30 and QLQ-STO 22

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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.

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 Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Gastric Adenocarcinoma

Intervention

• Drug: HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) with oxaliplatin
  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.
• Procedure: Curative gastrectomy
  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

Study Arms

• Experimental: Curative Gastrectomy + HIPEC
  Curative gastrectomy with D1-D2 lymph node dissection + HIPEC with oxaliplatin
  Interventions:

  • Drug: HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) with oxaliplatin
  • Procedure: Curative gastrectomy
• Curative Gastrectomy
  Curative gastrectomy with D1-D2 lymph node dissection
  Intervention: Procedure: Curative gastrectomy

• Publications *: 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: January 13, 2020): 367
• Original Estimated Enrollment (submitted: June 20, 2013): 322
• Estimated Study Completion Date: May 2026
• Estimated Primary Completion Date: May 2026 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France, Spain

Administrative Information

• NCT Number: NCT01882933
• Other Study ID Numbers: 2012.761
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Hospices Civils de Lyon
• Original Responsible Party: Same as current
• Current Study Sponsor: Hospices Civils de Lyon
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Olivier GLEHEN, MD; Service de Chirurgie Générale Digestive et Endocrinienne, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon

• PRS Account: Hospices Civils de Lyon
• Verification Date: April 2023