Status:
TERMINATED
S-1/Oxaliplatin for High Risk Patients Who Underwent Gastrectomy
Lead Sponsor:
Kangbuk Samsung Hospital
Conditions:
Stomach Cancer
Eligibility:
All Genders
20-75 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2019
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT02191566
Start Date
May 1 2015
End Date
October 1 2019
Last Update
December 8 2022
Active Locations (1)
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1
Kangbuk Samsung Hospital
Seoul, South Korea, 110-746