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S-1 for 9 Months Versus 1 Year for Stage II Gastric Cancer (SMAC）

NCT03941561 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1006

Last updated 2019-05-31

No results posted yet for this study

Summary

The study aims to compare the efficacy and safety of S-1 for 9 months versus S-1 for 1 year as adjuvant chemotherapy after D2 resection in patients with gastric cancer.

Hypothesis: For gastric patients after D2 resection, S-1 for 9 months shows non-inferiority to S-1 for 1 year in disease-free survival(DFS), overall survival (OS) and safety.

Conditions

Interventions

DRUG

S-1 for 9 months

S-1 for 9 months after D2 resection

DRUG

S-1 for 1 year

S-1 for 1 year after D2 resection

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Dazhi Xu, PHD, MD · Fudan 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
2019-01-01
Primary Completion
2022-01-01
Completion
2027-05-01

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 NCT03941561 on ClinicalTrials.gov