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Docetaxel Versus Oxaliplatin as Addition to S-1 for Stage II / III Gastric Adenocarcinoma

NCT03961867 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 440

Last updated 2021-06-01

No results posted yet for this study

Summary

S-1 plus oxaliplatin has been proved better than S-1 alone for stage II or III gastric cancer.

Docetaxel also showed excellent efficacy with S-1 in the postoperative setting for stage III gastric cancer.

This trial is designed to investigate the efficacy and safety of S-1 plus docetaxel versus S-1 plus oxalipltin as adjuvant chemotherapy after D2 resection in stage II / III gastric cancer.

Conditions

Interventions

DRUG

Docetaxel

S-1 (BSA \<1.25m2, 80 mg; 1.25 to 1.5m2, 100 mg; \>1.5m2,120 mg) divided into two doses /day after breakfast and dinner, 14 days / 3 weeks, totally 16 cycles. Docetaxel 40mg/m2/3w from the second to the seventh cycles.

DRUG

Oxaliplatin

S-1 (BSA \<1.25m2, 80 mg; 1.25 to 1.5m2, 100 mg; \>1.5m2,120 mg) divided into two doses /day after breakfast and dinner, 14 days / 3 weeks, totally 16 cycles. Oxaliplatin 130mg/m2/3w from the first to the eight cycles.

Sponsors & Collaborators

  • Sixth Affiliated Hospital, Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Jian Xiao, MD · Sixth Affiliated Hospital, Sun Yat-sen 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
2020-09-15
Primary Completion
2022-09-30
Completion
2025-09-30

Countries

  • China

Study Locations

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Entities

Drugs
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 NCT03961867 on ClinicalTrials.gov