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

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 Details

NCT ID
NCT03941561
Phase
PHASE3
Sponsor
Fudan University
Status
RECRUITING
Cancer Type
Gastric Cancer
Interventions
  • S-1 for 9 months
  • S-1 for 1 year
Locations (sample)
  • Anqing, China|30.51365,117.04723
  • Hangzhou, China|30.29365,120.16142
  • Hefei, China|31.86389,117.28083
  • Nanchang, China|28.68396,115.85306
  • Shanghai, China|31.22222,121.45806

Key Eligibility Criteria

  • The lower age limit of research subjects 18 years old and upper age limit of 75 years old.
  • Be proven to be primary adenocarcinoma of gastric cancer and staged II by pathological evidence
  • R0 surgery with lymphadenectomy
  • Without any other malignancies

For full eligibility, visit ClinicalTrials.gov.

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