Recruitment

Recruitment Status
Terminated
Estimated Enrollment
30

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 can be randomized within 6 weeks after surgery
...
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 can be randomized within 6 weeks after surgery
TNM stage (6th AJCC) of IIIB or IV on post-operative staging
Patients who underwent radical resection with wide lymph node dissection

Exclusion Criteria

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
Residual cancer on post-operative staging (R1 and R2 resection)
Aged < 20 years or ≥ 76 years
...
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
Residual cancer on post-operative staging (R1 and R2 resection)
Aged < 20 years or ≥ 76 years
Patients who received adjuvant chemotherapy, or neoadjuvant chemotherapy and/or radiotherapy and/or immunotherapy in the past for treatment of gastric cancer
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)
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
Eastern Cooperative Oncology Group (ECOG) performance status >2
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)

Summary

Conditions
Stomach Cancer
Type
Interventional
Phase
Phase 2
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 20 years and 75 years
Gender
Both males and females

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 can be randomized within 6 weeks after surgery
...
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 can be randomized within 6 weeks after surgery
TNM stage (6th AJCC) of IIIB or IV on post-operative staging
Patients who underwent radical resection with wide lymph node dissection

Exclusion Criteria

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
Residual cancer on post-operative staging (R1 and R2 resection)
Aged < 20 years or ≥ 76 years
...
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
Residual cancer on post-operative staging (R1 and R2 resection)
Aged < 20 years or ≥ 76 years
Patients who received adjuvant chemotherapy, or neoadjuvant chemotherapy and/or radiotherapy and/or immunotherapy in the past for treatment of gastric cancer
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)
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
Eastern Cooperative Oncology Group (ECOG) performance status >2
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)

Tracking Information

NCT #
NCT02191566
Collaborators
Not Provided
Investigators
  • Principal Investigator: Dong Hoe Koo, MD,PhD Kangbuk Samsung Hospital
  • Dong Hoe Koo, MD,PhD Kangbuk Samsung Hospital
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