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Chemosensitivity Test to Evaluate the Effect of Adjuvant Cancer Chemotherapy (S-1) After Gastric Surgery

Phase 2
20 Years
80 Years
Not Enrolling
Gastric Cancer

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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

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:


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:


Principal Investigator

Tetsuro Kubota, Processor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Keio University Hospital


Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

March 2006

Completion Date:

March 2011

Related Keywords:

  • Gastric Cancer
  • gastric cancer
  • S-1
  • chemosensitivity
  • adjuvant
  • Stomach Neoplasms