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RECRUITING
NCT03941561
PHASE3

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

Sponsor: Fudan University

View on ClinicalTrials.gov

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.

Official title: Compare S-1 for 9 Months to 1 Year as Adjuvant Chemotherapy in Stage II Gastric Cancer (SMAC)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

1006

Start Date

2019-01-01

Completion Date

2027-05-01

Last Updated

2019-05-31

Healthy Volunteers

No

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

Locations (6)

Anqing Municipal Hospital

Anqing, China

Second Affiliated Hospital, School of Medicine

Hangzhou, China

Anhui Provincial Hospital

Hefei, China

Jiangxi Provincial Cancer Hospital

Nanchang, China

Dazhi Xu

Shanghai, China

First Affiliated Hospital of Wannan Medical College

Wuhu, China