Chemosensitivity Test to Evaluate the Effect of Adjuvant Cancer Chemotherapy (S-1) After Gastric Surgery
Overview
- Phase
- Phase 2
- Intervention
- S-1
- Conditions
- Gastric Cancer
- Sponsor
- Japan Clinical Cancer Research Organization
- Enrollment
- 300
- Locations
- 36
- Primary Endpoint
- Overall survival rate
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- •multiple cancer
- •contraindication for S-1
- •history of drug allergy (grade 3)
- •severe complication
- •watery diarrhea
- •scirrhous gastric cancer
- •the other patients who was judged as inadequate for trial by doctor on duty
Arms & Interventions
1
Intervention: S-1
Outcomes
Primary Outcomes
Overall survival rate
Time Frame: at three years
Secondary Outcomes
- Side effect(During administration of drug)