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SOX Regimen as Neoadjuvant Chemotherapy for AJCC Stage II-III Gastric Cancer

NCT01583361 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 772

Last updated 2012-04-24

No results posted yet for this study

Summary

This is a randomized, multicenter, controlled trial to prove efficacy of S-1 and Oxaliplatin as Neoadjuvant Chemotherapy for Advanced Gastric Cancer Patients who undergo D2 gastrectomy.

The primary endpoint is three-year free disease and the second primary includes five-year overall survival, safety and R0 resection rate.

Conditions

  • Gastric Adenocarcinoma

Interventions

DRUG

Oxaliplatin+S-1

S-1: 40\~60mg bid，po, d1\~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，d1

DRUG

Adjuvant Oxaliplatin/S-1（SOX）

S-1：40\~60mg bid，d1\~14 q3W oxaliplatin：130mg/m2，iv drip for 2h，d1,q3W 8 cycles (6 months)

Sponsors & Collaborators

  • Lin Chen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2014-09-30
Completion
2017-01-31

Countries

  • China

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 NCT01583361 on ClinicalTrials.gov