A Phase II Trial of Adjuvant Chemotherapy With S-1 Plus Oxaliplatin for Locally Advanced Gastric Cancer
Conditions
Advanced Gastric Cancer
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
Oxaliplatin, S-1, Gastric cancer, Adjuvant chemotherapy
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 plus oxaliplatin
Type: Drug
Overall Status
Recruiting
Summary
Patients with advanced gastric cancer have showed poor prognosis. Only 81% of the patients could underwent curative surgery. In those, about 60% of patients would survive after 5 years from the surgery. As a result, role of chemotherapy has been increased. In ACTS-GC trial, S-1 adjuvant therapy after D2 gastrectomy increased overall survival rate in advanced gastric cancer patients. However, subgroup analysis showed that S-1 adjuvant therapy was insufficient in patients with stage III or IV (according to the AJCC 6th criteria) gastric cancer. In addition, CLASSIC trial demonstrated that oxaliplatin plus capecitabine adjuvant therapy could increase disease-free survival after D2 gastrectomy in advanced gastric cancer patients. Notwithstanding these trial, optimal adjuvant regimen of advanced gastric cancer has not been established. We aimed to evaluate efficacy of S-1 plus oxaliplatin as adjuvant chemotherapy after D2 gastrectomy in stage III (according to the AJCC 7th criteria) gastric cancer patients.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 19 Years
Gender: Both
Criteria: Inclusion Criteria:

- Age, between 19 and 75

- Histologically proven advanced gastric cancer

- R0 resection after D2 gastrectomy

- Stage III (according to the AJCC 7th criteria)

- ECOG status 0 to 2

Exclusion Criteria:

- Malignancy history other than gastric cancer

- Previous chemotherapy history for gastric cancer

- Previous radiotherapy history for gastric cancer

- Pregnancy or breast milk feeding

- Grade 3 or more of neuropathy

- Active infection

- Severe hepatic dysfunction

- Severe renal dysfunction

- Severe bone marrow dysfunction

- Significant neurologic or psychologic disease

- Inadequate condition for receiving chemotherapy due to significant systemic disease

- Patients who receives drugs which can be interacted with S-1
Location
Severnace Hospital
Seoul, Korea, Republic of
Status: Recruiting
Contact: Yong Chan Lee, MD - 82-2-2228-1960 - leeyc@yuhs.ac
Start Date
September 2013
Completion Date
September 2018
Sponsors
Yonsei University
Source
Yonsei University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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