Chemosensitivity Test to Evaluate the Effect of Adjuvant Cancer Chemotherapy (S-1) After Gastric Surgery
Patients: clinical Stage III gastric cancer patients. Informed consent will be obtained
before surgery. Eligible patients: surgical Stage II, IIIA and IIIB gastric cancer patients.
Chemosensitivity test: The surgical specimen will be sent Mitsubishi BCL, Co. Ltd. to be
tested by CD-DST chemosensitivity test and RT-PCR for thymidylate synthetase and
dihydropyrimidine dehydrogenase mRNA. The test results will be blinded for the doctors on
Treatment: All the patients will be treated with S-1 at a dose of 80 mg/m2 b.i.d. for 4
weeks followed by 2 weeks rest. The treatment will be continued until the recurrence or 1
year after operation.
Primary endpoint: 3-years disease-free survival rate Secondary endpoint: 3-years overall
survival rate and side effect (CTCAE v3.0) Evaluation of chemosensitivity test: The cutoff
condition will be determined based on the accumulated data of CD-DST and mRNAs.
Hypothesis: The responder detected by CD-DST and/or TS, DPD mRNA will have a favorable
survival outcome comparing with resistant cases.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic
Overall survival rate
at three years
Tetsuro Kubota, Processor
Keio University Hospital
Japan: Ministry of Health, Labor and Welfare