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A Efficacy and Tolerability Study of TEGAFOX Sequential S-1 in the Treatment of Adjuvant Chemotherapy for Gastric Cancer

NCT02817425 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2016-06-29

No results posted yet for this study

Summary

This study is designed to compare the three chemotherapy regimens(TEGAFOX Sequential S-1 or SOX Sequential S-1 or SOX non-Sequential S-1) for postoperative patients with gastric cancer, observe and record the efficacy and tolerance,to evaluate which regimen is better.

Conditions

Interventions

DRUG

SOX Sequential S-1

8 cycles SOX followed by S-1 monotherapy until disease progression. S-1: 40 mg/m2 bid,po, day 1 \~14 (S-1：BSA \<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA\>1.5m2, 60mg bid) Oxaliplatin: 130 mg/m2 iv 2h,day 1.Every 21 days as a cycle.

DRUG

SOX

S-1: 40 mg/m2 bid,po, day 1 \~14 (S-1：BSA \<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA\>1.5m2, 60mg bid) Oxaliplatin: 130 mg/m2 iv 2h,day 1. Every 21 days as a cycle

DRUG

TEGAFOX Sequential S-1.

6 cycles TEGAFOX followed by S-1 monotherapy until disease progression. S-1: 40 mg/m2 bid,po, day 1 \~14 (S-1：BSA \<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA\>1.5m2, 60mg bid) Oxaliplatin: 130 mg/m2 iv 2h,day 1. TF 1000 mg/m2 with calcium folinate 300 mg/m2 IV infusion from Day 1 to Day 5 Every 28 days as a cycle.

Sponsors & Collaborators

  • LanZhou University

    lead OTHER

Principal Investigators

  • Xiao Chen, MD · Second Hospital Affiliated to Lanzhou University

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
2013-05-31
Primary Completion
2018-04-30
Completion
2019-05-31

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 NCT02817425 on ClinicalTrials.gov