D2 Resection and HIPEC (Hyperthermic intraperitoneal chemoperfusion) in locally advanced gastric carcinoma. A national randomized and multicentric phase III study

D2 Resection and HIPEC (Hyperthermic intraperitoneal chemoperfusion) in locally advanced gastric carcinoma. A national randomized and multicentric phase III study - GASTRICHIP

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-005748-12-FR

Enrollment

322

Registered

2013-04-19

Start date

2013-04-26

Completion date

Unknown

Last updated

2024-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric adenocarcinoma MedDRA version: 19.1 Level: LLT Classification code 10017770 Term: Gastric carcinoma System Organ Class: 100000004864

Interventions

Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: OXALIPLATIN CAS Number: 61825-94-3 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration n

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -18 3,500/mm3, neutrophils = 1,500/mm3, platelets = 100,000/mm3 - Good renal functions, serum creatinine values being =65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: - Prior malignant tumors with detectable signs of recurrence - Gastric stump adenocarcinoma - Presence of comorbidities, notably serious chronic diseases or organ failure - Any subject in exclusion period of a previous study according to applicable regulations - Pregnancy or breastfeeding - Females of childbearing age potential not using medically accepted contraceptive measures, as judged by the investigator Interfering substance - Contraindication to any drug contained in the chemotherapy regimen - 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

Design outcomes

Primary

Measure	Time frame
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 cytology), treated either with curative gastrectomy and adjuvant Hyperthermic Intraperitoneal Chemotherapy (HIPEC) (Arm A), or with curative gastrectomy alone (Arm B).;Secondary Objective: - Compare 3-year and 5-year recurrence-free survival; - Study the incidence of locoregional recurrence and compare locoregional recurrence-free 5-year survival; - Assess and compare treatment-related toxicity (Common Terminology Criteria for Adverse Events v4.0); - Compare sites of recurrence; - Identify prognostic factors of overall 5-year survival and recurrence-free 5-year survival; - Compare patients’ quality of life at preoperative time, M3, M6 and M12 and changes of quality of life. ;Primary end point(s): Overall survival ;Timepoint(s) of evaluation of this end point: 5 years (end of follow-up)	—

Measure

Time frame

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 cytology), treated either with curative gastrectomy and adjuvant Hyperthermic Intraperitoneal Chemotherapy (HIPEC) (Arm A), or with curative gastrectomy alone (Arm B).;Secondary Objective: - Compare 3-year and 5-year recurrence-free survival; - Study the incidence of locoregional recurrence and compare locoregional recurrence-free 5-year survival; - Assess and compare treatment-related toxicity (Common Terminology Criteria for Adverse Events v4.0); - Compare sites of recurrence; - Identify prognostic factors of overall 5-year survival and recurrence-free 5-year survival; - Compare patients’ quality of life at preoperative time, M3, M6 and M12 and changes of quality of life. ;Primary end point(s): Overall survival ;Timepoint(s) of evaluation of this end point: 5 years (end of follow-up)

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Secondary

Measure	Time frame
Secondary end point(s): 1) Recurrence-free survivals (peritoneal recurrence, locoregional recurrence, metastatic recurrence, site of recurrence ) 2) Treatment-related toxicity 3) Treatment-related mortality 4) Treatment related morbidity 5) Quality of life;Timepoint(s) of evaluation of this end point: 1) 3 years and 5 years 2) During the 60th postoperative days 3) During the 60th postoperative days 4) During the 60th postoperative days 5) At preoperative time, M3, M6 and M12 postoperative	—

Measure

Time frame

Secondary end point(s): 1) Recurrence-free survivals (peritoneal recurrence, locoregional recurrence, metastatic recurrence, site of recurrence ) 2) Treatment-related toxicity 3) Treatment-related mortality 4) Treatment related morbidity 5) Quality of life;Timepoint(s) of evaluation of this end point: 1) 3 years and 5 years 2) During the 60th postoperative days 3) During the 60th postoperative days 4) During the 60th postoperative days 5) At preoperative time, M3, M6 and M12 postoperative

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Countries

France, Spain

Contacts

Public ContactClinical Trial Information

Hospices Civils de Lyon

valerie.plattner@chu-lyon.fr472 115 213+33

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026