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The Long-term Effect of D4 Lymphadenectomy for Gastric Cancer

NCT02423278 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2015-04-22

No results posted yet for this study

Summary

The main purpose of this study is to evaluate the effect of extensive lymphadenectomy procedure in treatment of gastric cancer. This study is designed as a open-label, multi-centers, randomized controlled trial. The overall survival and free disease survival are primary outcomes, with postoperative complication, hospital charges, and life quality as secondary outcomes.

Conditions

Interventions

PROCEDURE

Radical Gastrectomy Plus D2 Lymphadenectomy

This surgical procedure is performed by the same high-experienced surgical team as the control arm. All lymph nodes around stomach (station 1\&2 LNs) must be removed to achieve a radical lymphadenectomy. Para-aortic lymph nodes should not be dissected even if a suspected lymph node metastasis is diagnosed from radiographic exams.

PROCEDURE

Radical Gastrectomy Plus D4 Lymphadenectomy

This surgical procedure is also performed by the same high-experienced surgical team as the control arm. Lymph nodes around stomach (station 1\&2 LNs) and para-aortic lymph nodes must be removed during the operation.

DRUG

S-1+Oxaliplatin

A perioperative chemotherapy, known as SOX regimen, should be performed in each enrolled patient with three-cycle treatments followed after a pathological carcinoma diagnosis. After a radical operation (arm groups), additional five-cycle treatments of adjuvant chemotherapy (SOX regimen) would be performed, followed by follow-up program. The treatment bundles are listed as follows: * S-1: 40\~60mg bid，po, Day1\~14 （S-1：BSA \<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA\>1.5m2, 60mg bid） * Oxaliplatin: 130mg/m2，iv drip for 2h，Day1

Sponsors & Collaborators

  • Second Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER

  • Third Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER

  • Sixth Affiliated Hospital, Sun Yat-sen University

    collaborator OTHER

  • First Affiliated Hospital, Sun Yat-Sen University

    lead OTHER

Principal Investigators

  • Yulong He, MD · First Affiliated Hospital, Sun Yat-Sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2016-06-30
Completion
2020-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT02423278 on ClinicalTrials.gov