S-1/Oxaliplatin for High Risk Patients Who Underwent Gastrectomy
Last updated on April 2022Recruitment
- Recruitment Status
- Terminated
- Estimated Enrollment
- 30
Inclusion Criteria
- Patients who can be randomized within 6 weeks after surgery
- Patients who underwent radical resection with wide lymph node dissection
- Newly definitely diagnosed with primary gastric or gastroesophageal junction adenocarcinoma histologically
- ...
- Patients who can be randomized within 6 weeks after surgery
- Patients who underwent radical resection with wide lymph node dissection
- Newly definitely diagnosed with primary gastric or gastroesophageal junction adenocarcinoma histologically
- Patients who voluntarily provide written informed consent prior to entering into this study
- TNM stage (6th AJCC) of IIIB or IV on post-operative staging
Exclusion Criteria
- Aged < 20 years or ≥ 76 years
- Patients who underwent surgery for neoplasm in stomach in the past
- 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)
- ...
- Aged < 20 years or ≥ 76 years
- Patients who underwent surgery for neoplasm in stomach in the past
- 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)
- 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
- 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
- History of hypersensitivity to the investigational products (S1 and Oxaliplatin)
- Patients who received adjuvant chemotherapy, or neoadjuvant chemotherapy and/or radiotherapy and/or immunotherapy in the past for treatment of gastric cancer
- Residual cancer on post-operative staging (R1 and R2 resection)
- Pregnant women, breastfeeding women, or women of childbearing potential whose pregnancy test result is positive•
- Eastern Cooperative Oncology Group (ECOG) performance status >2
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 can be randomized within 6 weeks after surgery
- Patients who underwent radical resection with wide lymph node dissection
- Newly definitely diagnosed with primary gastric or gastroesophageal junction adenocarcinoma histologically
- ...
- Patients who can be randomized within 6 weeks after surgery
- Patients who underwent radical resection with wide lymph node dissection
- Newly definitely diagnosed with primary gastric or gastroesophageal junction adenocarcinoma histologically
- Patients who voluntarily provide written informed consent prior to entering into this study
- TNM stage (6th AJCC) of IIIB or IV on post-operative staging
Exclusion Criteria
- Aged < 20 years or ≥ 76 years
- Patients who underwent surgery for neoplasm in stomach in the past
- 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)
- ...
- Aged < 20 years or ≥ 76 years
- Patients who underwent surgery for neoplasm in stomach in the past
- 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)
- 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
- 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
- History of hypersensitivity to the investigational products (S1 and Oxaliplatin)
- Patients who received adjuvant chemotherapy, or neoadjuvant chemotherapy and/or radiotherapy and/or immunotherapy in the past for treatment of gastric cancer
- Residual cancer on post-operative staging (R1 and R2 resection)
- Pregnant women, breastfeeding women, or women of childbearing potential whose pregnancy test result is positive•
- Eastern Cooperative Oncology Group (ECOG) performance status >2
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