S-1/Oxaliplatin for High Risk Patients Who Underwent Gastrectomy (SOHUG)

Kangbuk Samsung Hospital

Status and phase: Terminated; Phase 2

Conditions: Stomach Cancer

Treatments: Drug: OXALIPLATIN (205803BIJ); Drug: S-1 (452500ACH)

Study type: Interventional

Funder types: Other

Identifiers

NCT02191566

SOHUG

Details and patient eligibility

About

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).

Enrollment: 8 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

S-1/Oxaliplatin

Experimental group

Description:

S-1 80 mg/m²/day from day 1 to day 14, every 21 days, for 12 months; Oxaliplatin 130 mg/m² for day 1, every 21 days, for 6 months

Treatment:

Drug: S-1 (452500ACH)

Drug: OXALIPLATIN (205803BIJ)