S-1/Oxaliplatin for High Risk Patients Who Underwent Gastrectomy
Conditions
Stomach Cancer
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
Stomach Cancer
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: S-1 (452500ACH) Type: Drug
Name: OXALIPLATIN (205803BIJ) Type: Drug
Overall Status
Recruiting
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).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 20 Years
Gender: Both
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)
Location
Kangbuk Samsung Hospital
Seoul, Korea, Republic of
Status: Recruiting
Contact: Dong-Hoe Koo, MD,PhD - +82-2-2001-8330 - d.h.koo@samsung.com
Start Date
November 2014
Completion Date
February 2019
Sponsors
Kangbuk Samsung Hospital
Source
Kangbuk Samsung Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page