RecruitingPhase 3NCT03941561

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

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

Sponsor

Fudan University

Enrollment

1,006 participants

Start Date

Jan 1, 2019

Study Type

INTERVENTIONAL

Conditions

Gastric Cancer

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two different lengths of treatment with a chemotherapy drug called S-1 (an oral chemotherapy) after surgery for stage II stomach cancer. One group takes it for 9 months and the other for 12 months, to find out if a shorter course is just as effective with fewer side effects. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with stage II stomach (gastric) adenocarcinoma confirmed by biopsy - You have undergone complete surgical removal of the tumor (R0 resection) with lymph node removal - You have no other cancers - You are in good physical condition (ECOG score 0–1) **You may NOT be eligible if...** - Your cancer has come back or spread - You have had prior chemotherapy or radiation for this cancer - You have serious heart, liver, or kidney problems - You are pregnant or breastfeeding - You have had another cancer in the past 5 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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