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A Randomized Phase III Study of Adjuvant Chemotherapy With or Without Chemo-radiotherapy in Patients With Local Advanced Gastric Cancer After D2 Resection.

NCT02648841 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 588

Last updated 2016-01-07

No results posted yet for this study

Summary

The purpose of this study is to explore the role of adjuvant chemo-radiotherapy in patients with local advanced gastric cancer.

Conditions

Interventions

RADIATION

Adjuvant Concurrent Chemo-radiotherapy

Adjuvant concurrent chemo-radiotherapy will be given to the patients in the Experimental group after 4-6 cycles of SOX chemotherapy. Total dose of 45Gy is delivered by IMRT Radiotherapy technique. The concurrent chemotherapy regimen is as follow: S-1 40-60mg Bid, Oral.

DRUG

Adjuvant chemotherapy for active comparator group

8 cycles of SOX adjuvant chemotherapy will be given to the patients in the active comparator group. The SOX chemotherapy regimen is as follow: S-1 40-60mg Bid, Oral, D1-14, Q21D; Oxaliplatin 130mg/m2, ivgtt, D1, Q21d.

DRUG

Adjuvant chemotherapy for experimental group

6 cycles of SOX adjuvant chemotherapy will be given to the patients in the experimental group. The SOX chemotherapy regimen is as follow: S-1 40-60mg Bid, Oral, D1-14, Q21D; Oxaliplatin 130mg/m2, ivgtt, D1, Q21d.

Sponsors & Collaborators

  • Chinese Academy of Medical Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2020-06-30
Completion
2022-06-30

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 NCT02648841 on ClinicalTrials.gov