Clinical Trial of Chemosensitivity Test

Japan Clinical Cancer Research Organization

Status and phase: Completed; Phase 2

Conditions: Gastric Cancer

Treatments: Drug: S-1

Study type: Interventional

Funder types: Other

Identifiers

NCT00287755

JACCRO GC-04

GC-04

Details and patient eligibility

About

To evaluate the usefulness of chemosensitivity test in evaluating the appropriate adjuvant cancer chemotherapy after gastric surgery

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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300 participants in 1 patient group

1

Experimental group

Treatment:

Drug: S-1