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

Recruiting Phase 3 Interventional Study
Gastric Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
1,006 (estimated)
Sponsor
Fudan University · Other
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. The lower age limit of research subjects 18 years old and upper age limit of 75 years old. 2. Be proven to be primary adenocarcinoma of gastric cancer and staged II by pathological evidence 3. R0 surgery with lymphadenectomy 4. Without any other malignancies 5. ECOG (ECOG sco…
Contacts

Dazhi Xu, PHD, MD

(+86) 020-87343737

xudzh@sysucc.org.cn

CONTACT