S-1/Oxaliplatin for High Risk Patients Who Underwent Gastrectomy
Phase 2
Terminated
- Conditions
- Stomach Cancer
- Interventions
- Registration Number
- NCT02191566
- Lead Sponsor
- Kangbuk Samsung Hospital
- Brief Summary
After curative resection, patients with stage IIIB-IV (M0) gastric cancer were given chemotherapy as follows: S-1 orally at 80 mg/m2 divided in two daily doses for 14 days and oxaliplatin at 130 mg/m2 intravenously over 2 h every 21 days as one cycle. S1 was administered for 16 cycles (12 months) and oxaliplatin for 8 cycles (6 months).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 8
Inclusion Criteria
- Patients who voluntarily provide written informed consent prior to entering into this study
- Newly definitely diagnosed with primary gastric or gastroesophageal junction adenocarcinoma histologically
- Patients who underwent radical resection with wide lymph node dissection
- TNM stage (6th AJCC) of IIIB or IV on post-operative staging
- Patients who can be randomized within 6 weeks after surgery
Exclusion Criteria
- Aged < 20 years or ≥ 76 years
- Eastern Cooperative Oncology Group (ECOG) performance status >2
- Patients who underwent surgery for neoplasm in stomach in the past
- History of malignant disease The following cases can be included in this study - adequately treated basal cell or squamous cell skin cancer, cervical carcinoma in situ
- Gastric or gastroesophageal junction adenocarcinoma with distant metastasis (M1) including distant lymph node (behind the pancreas, along the aorta, portal vein, behind the peritoneum, mesenteric lymph node)
- Residual cancer on post-operative staging (R1 and R2 resection)
- Patients who received adjuvant chemotherapy, or neoadjuvant chemotherapy and/or radiotherapy and/or immunotherapy in the past for treatment of gastric cancer
- Any of the following within 6 months prior to the study recruitment: Myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass, NYHA class III or IV congestive heart failure, stroke or transient ischemic attack, serious cardiac arrhythmia requiring treatment
- Patients of childbearing potential who do not agree to use generally accepted effective method of birth control during the study treatment period and for at least 6 months after the end of study treatment
- Pregnant women, breastfeeding women, or women of childbearing potential whose pregnancy test result is positive•
- History of hypersensitivity to the investigational products (S1 and Oxaliplatin)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description S-1/Oxaliplatin S-1 (452500ACH) S-1 80 mg/m²/day from day 1 to day 14, every 21 days, for 12 months; Oxaliplatin 130 mg/m² for day 1, every 21 days, for 6 months S-1/Oxaliplatin OXALIPLATIN (205803BIJ) S-1 80 mg/m²/day from day 1 to day 14, every 21 days, for 12 months; Oxaliplatin 130 mg/m² for day 1, every 21 days, for 6 months
- Primary Outcome Measures
Name Time Method 3-year recurrence-free survival, RFS 3-year
- Secondary Outcome Measures
Name Time Method 5-year overall survival, OS 5-year
Trial Locations
- Locations (1)
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of