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

NCT01882933 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 367

Last updated 2024-05-08

No results posted yet for this study

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.

Conditions

  • Gastric Adenocarcinoma

Interventions

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

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Principal Investigators

  • Olivier GLEHEN, MD · Service de Chirurgie Générale Digestive et Endocrinienne, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2026-05-31
Completion
2026-05-31

Countries

  • France
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01882933 on ClinicalTrials.gov