Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:07 PM
Ignite Modification Date:
2025-12-24 @ 4:07 PM
NCT ID:
NCT02191566
Eligibility Criteria:
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
75 Years
Study:
NCT02191566
Study Brief:
Protocol Section:
NCT02191566