Gastric Adenocarcinoma
Conditions
Keywords
Gastric adenocarcinoma, HIPEC, Oxaliplatin, Signet ring cell
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.
Interventions
DRUGHIPEC (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.
PROCEDURECurative 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
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 5 years | From the date of surgery to the date of death or to the end of follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence-free survival | 5 years | From the date of surgery to the date of recurrence or to the end of follow-up |
| Locoregional-free survival | 5 years | From the date of surgery to the date of locoregional recurrence or to the end of follow-up |
| Treatment-related morbidity | During the 60th postoperative days | Common Terminology Criteria for Adverse Events v4.0 |
| Treatment-related mortality | During the 60th postoperative days | — |
| Score QLQ-C30 | 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 | 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 |
Countries
France, Spain
Contacts
PRINCIPAL_INVESTIGATOROlivier GLEHEN, MD
Service de Chirurgie Générale Digestive et Endocrinienne, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon
Outcome results
None listed