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

Phase 1

• Conditions: Gastric adenocarcinoma; MedDRA version: 19.1Level: LLTClassification code 10017770Term: Gastric carcinomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2012-005748-12-FR
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-19
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 322

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
- 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
Specific to the study
- 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 222
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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;<br>- Study the incidence of locoregional recurrence and compare locoregional recurrence-free 5-year survival;<br>- Assess and compare treatment-related toxicity (Common Terminology Criteria for Adverse Events v4.0);<br>- Compare sites of recurrence;<br>- Identify prognostic factors of overall 5-year survival and recurrence-free 5-year survival;<br>- Compare patients’ quality of life at preoperative time, M3, M6 and M12 and changes of quality of life.<br>;Primary end point(s): Overall survival ;Timepoint(s) of evaluation of this end point: 5 years (end of follow-up)

Secondary Outcome Measures

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