S-1 for 9 Months Versus 1 Year for Stage II Gastric Cancer (SMAC）
Recruiting now · Phase 3
Conditions studied: Gastric Cancer
In brief
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.
Key facts
- Study ID
- NCT03941561
- Run by
- Fudan University
- People needed
- 1006
- Starts
- 2019-01-01
- Expected to finish
- 2027-05-01
- Last updated by the study team
- 2019-05-31
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
- ECOG (ECOG score standard) performance status of 0 or 1 and expected to survive more than 6 months
- 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).
You may not qualify if…
- Female in pregnancy or lactation, or refuse to receive Contraception measures during chemotherapy.
- Patients with stage I, III and IV.
- Unavailable for R0 resection and D2 lymph node dissection.
- Suffering from other uncontrolled diseases, such as other tumors, acute and Chronic infection.
- With severe heart disease, including congestive heart failure, uncontrolled arrhythmias, unstable angina, myocardial infarction, severe heart valve disease, and resistant hypertension.
- Any Known or suspected history of drug allergy test.
- The researchers believe the patient is not able to complete the entire course of the experiment.
- Patients (within 4 weeks) are receiving any other anti-cancer drugs therapy, biological therapy, radiation therapy, or Immunosuppressive therapy.
- Patients conform to any of the following: post-organ transplant, necessary for long-term immunosuppressive or suffering with autoimmune diseases.
Where it is running
- Anqing Municipal Hospital — Anqing, China (enrolling)
- Second Affiliated Hospital, School of Medicine — Hangzhou, China (enrolling)
- Anhui Provincial Hospital — Hefei, China (enrolling)
- Jiangxi Provincial Cancer Hospital — Nanchang, China (enrolling)
- Dazhi Xu — Shanghai, China (enrolling)
- First Affiliated Hospital of Wannan Medical College — Wuhu, China (enrolling)
Full record on ClinicalTrials.gov
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