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Compare Neoadjuvant Chemotherapy of DOS Versus SOX in Locally Advanced Gastric Adenocarcinoma.

NCT03691454 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 258

Last updated 2018-10-01

No results posted yet for this study

Summary

This is a randomized, multicenter, controlled, adaptive phase II/III clinical study. The aim is to compare neoadjuvant chemotherapy of Docetaxel，Oxaliplatin combined with S-1(DOS) versus Oxaliplatin combined with S-1(SOX) in locally advanced gastric adenocarcinoma

Conditions

  • Gastric Adenocarcinoma

Interventions

DRUG

Docetaxel

Docetaxel 50mg/m2, intravenous drip, D1, combined with Oxaliplatin 85mg/m2，intravenous drip 2h，D1 and S-1 40-60mg bid(BSA\<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2, 50mg bid, BSA\>1.5m2, 60mg bid)，D1-7；For patients with Her2 positive, add Herceptin 4mg/kg(6mg/kg first cycle) D1; every 14 days for a cycle.

DRUG

Oxaliplatin

Oxaliplatin 130mg/m2，intravenous drip 2h，D1 combined with S-1 40-60mg bid(BSA\<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2, 50mg bid, BSA\>1.5m2, 60mg bid)，D1-14；For patients with Her2 positive, add Herceptin 6mg/kg(8mg/kg first cycle) D1; every 21 days for a cycle.

Sponsors & Collaborators

  • Peking University

    lead OTHER

Principal Investigators

  • Jiafu Ji, Professor · Peking University Cancer Hospital & Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-28
Primary Completion
2022-06-30
Completion
2023-06-30

Countries

  • China

Study Locations

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Entities

Drugs

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 NCT03691454 on ClinicalTrials.gov