Comparing 9 months versus 1 year of S-1 chemotherapy for stage II gastric cancer
Compare S-1 for 9 Months to 1 Year as Adjuvant Chemotherapy in Stage II Gastric Cancer (SMAC）
This study is testing whether 9 months of S-1 chemotherapy is just as effective and safe as 1 year of treatment for people with stage II gastric cancer who have had surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1006 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 6 sites (Anqing and 5 other locations) |
| Trial ID | NCT03941561 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the efficacy and safety of S-1 chemotherapy administered for 9 months compared to 1 year in patients with stage II gastric cancer who have undergone D2 resection. Participants will be randomly assigned to receive either treatment regimen, with the primary endpoint being disease-free survival over three years and secondary endpoints including overall survival over five years. The study seeks to determine if a shorter duration of S-1 is equally effective and safer than the standard one-year treatment. The trial will involve patients aged 18 to 75 with confirmed stage II gastric cancer and adequate organ function.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 18 to 75 with histologically confirmed stage II gastric cancer who have undergone D2 resection.
Not a fit: Patients with stage I, III, or IV gastric cancer, or those with other uncontrolled diseases, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a shorter, equally effective treatment option for patients with stage II gastric cancer, potentially improving their quality of life.
How similar studies have performed: Previous studies have shown S-1 to be an effective treatment for gastric cancer, but this specific comparison of treatment durations is novel.
Eligibility criteria
Show full inclusion / exclusion 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 score standard) performance status of 0 or 1 and expected to survive more than 6 months 6. No contraindications to chemotherapy, including normal peripheral blood routine, liver, and kidney function and electrocardiogram （WBC≥4.0 x 109 /L, NEU≥1.5 x 109 /L, PLT≥100 x 109 /L and HGB≥90g/L). Exclusion Criteria: 1. Female in pregnancy or lactation, or refuse to receive Contraception measures during chemotherapy. 2. Patients with stage I, III and IV. 3. Unavailable for R0 resection and D2 lymph node dissection. 4. Suffering from other uncontrolled diseases, such as other tumors, acute and Chronic infection. 5. With severe heart disease, including congestive heart failure, uncontrolled arrhythmias, unstable angina, myocardial infarction, severe heart valve disease, and resistant hypertension. 6. Any Known or suspected history of drug allergy test. 7. The researchers believe the patient is not able to complete the entire course of the experiment. 8. Patients (within 4 weeks) are receiving any other anti-cancer drugs therapy, biological therapy, radiation therapy, or Immunosuppressive therapy. 9. Patients conform to any of the following: post-organ transplant, necessary for long-term immunosuppressive or suffering with autoimmune diseases.
Where this trial is running
Anqing and 5 other locations
- Anqing Municipal Hospital — Anqing, China (Recruiting)
- Second Affiliated Hospital, School of Medicine — Hangzhou, China (Recruiting)
- Anhui Provincial Hospital — Hefei, China (Recruiting)
- Jiangxi Provincial Cancer Hospital — Nanchang, China (Recruiting)
- Dazhi Xu — Shanghai, China (Recruiting)
- First Affiliated Hospital of Wannan Medical College — Wuhu, China (Recruiting)
Study contacts
- Principal investigator: Dazhi Xu, PHD, MD — Fudan University
- Study coordinator: Dazhi Xu, PHD, MD
- Email: xudzh@sysucc.org.cn
- Phone: (+86) 020-87343737
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.