Actively Recruiting
S-1 for 9 Months Versus 1 Year for Stage II Gastric Cancer (SMAC）
Led by Fudan University · Updated on 2019-05-31
1006
Participants Needed
6
Research Sites
434 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
S-1 for 9 Months Versus 1 Year for Stage II Gastric Cancer (SMAC）
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old
- Histologically confirmed primary adenocarcinoma of stage II gastric cancer
- Completed R0 surgery with D2 lymphadenectomy
- No other malignancies present
- ECOG performance status of 0 or 1 with expected survival over 6 months
- No contraindications to chemotherapy, including normal blood counts, liver and kidney function, and ECG
You will not qualify if you...
- Female who is pregnant, breastfeeding, or unwilling to use contraception during chemotherapy
- Patients with stage I, III, or IV gastric cancer
- Not eligible for R0 resection or D2 lymph node dissection
- Presence of other uncontrolled diseases such as other tumors or acute/chronic infections
- Severe heart disease including congestive heart failure, uncontrolled arrhythmias, unstable angina, myocardial infarction, severe valve disease, or resistant hypertension
- Known or suspected drug allergy
- Inability to complete the entire study treatment
- Receiving other anti-cancer, biological, radiation, or immunosuppressive therapies within the past 4 weeks
- History of organ transplant, long-term immunosuppressive therapy, or autoimmune diseases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Anqing Municipal Hospital
Anqing, China
Actively Recruiting
2
Second Affiliated Hospital, School of Medicine
Hangzhou, China
Actively Recruiting
3
Anhui Provincial Hospital
Hefei, China
Actively Recruiting
4
Jiangxi Provincial Cancer Hospital
Nanchang, China
Actively Recruiting
5
Dazhi Xu
Shanghai, China
Actively Recruiting
6
First Affiliated Hospital of Wannan Medical College
Wuhu, China
Actively Recruiting
Research Team
D
Dazhi Xu, PHD, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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