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A Comparison of Laparoscopic With Open Distal Gastrectomy in Advanced Gastric Cancer After Neoadjuvant Chemotherapy

NCT02404753 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2018-09-28

No results posted yet for this study

Summary

The purpose of the study is to evaluate the safety and efficacy of laparoscopic distal D2 gastrectomy (LDG) compared with open surgery (ODG) for resectable gastric cancer, to determine whether LDG can be a test arm for a future Phase III trial to evaluate the non-inferiority of overall survival compared with ODG in patients who receive neoadjuvant chemotherapy.

Conditions

Interventions

DRUG

Neoadjuvant Chemotherapy

XELOX: Oxaliplatin 130mg/m2,iv.,d1;Capecitabine 1000mg/m2,po.,Bid,d1-14; Repeat every 21 days for 3 courses.

PROCEDURE

Laparoscopic gastrectomy

Laparoscopic distal gastrectomy with D2 lymph node dissection

PROCEDURE

Open gastrectomy

Open distal gastrectomy with D2 lymph node dissection

DRUG

Adjuvant Chemotherapy

XELOX: Oxaliplatin 130mg/m2,iv.,d1;Capecitabine 1000mg/m2,po.,Bid,d1-14; Repeat every 21 days for 5 courses.

Sponsors & Collaborators

  • Beijing Municipal Science & Technology Commission

    collaborator OTHER

  • Peking University

    lead OTHER

Principal Investigators

  • Ziyu Li, M.D. · Peking University Cancer Hospital & Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2020-11-25
Completion
2022-11-25

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 NCT02404753 on ClinicalTrials.gov