Chemosensitivity Test to Evaluate the Effect of Adjuvant Cancer Chemotherapy (S-1) After Gastric Surgery
20 Years
80 Years
Both
Gastric Cancer
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic
Outcome Measure:
Overall survival rate
Outcome Time Frame:
at three years
Safety Issue:
No
Principal Investigator
Tetsuro Kubota, Processor
Investigator Role:
Principal Investigator
Investigator Affiliation:
Keio University Hospital
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
JACCRO GC-04
NCT ID:
NCT00287755
Start Date:
March 2006
Completion Date:
March 2011
Related Keywords:
- Gastric Cancer
- gastric cancer
- S-1
- chemosensitivity
- adjuvant
- Stomach Neoplasms
Name | Location |
|---|
