Gastric Cancer
Conditions
Keywords
gastric cancer, S-1, chemosensitivity, adjuvant
Brief summary
To evaluate the usefulness of chemosensitivity test in evaluating the appropriate adjuvant cancer chemotherapy after gastric surgery
Detailed description
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 duty. 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.
Interventions
DRUGS-1
S-1 capsule at a dose of 80 mg/m2 b.i.d. for 4 weeks followed by 2 weeks rest.
Sponsors
Kitasato University
Japan Clinical Cancer Research Organization
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* histologically proven gastric cancer * PS (ECOG) 0 or 2 * D2 dissection, curability B or more * surgical Stage IIIA and IIIB * negative peritoneal cytology * no previous radiotherapy, chemotherapy and hormone therapy * possible peroral intake at 6 POW * no severe surgical complication * normal bone marrow, liver and renal function * complete chemosensitivity test * written informed consent
Exclusion criteria
* multiple cancer * contraindication for S-1 * history of drug allergy (grade 3) * severe complication * watery diarrhea * pregnant * scirrhous gastric cancer * the other patients who was judged as inadequate for trial by doctor on duty
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival rate | at three years |
Secondary
| Measure | Time frame |
|---|---|
| Side effect | During administration of drug |
Countries
Japan
Outcome results
None listed