Clinical Trial of Chemosensitivity Test
- Registration Number
- NCT00287755
- Lead Sponsor
- Japan Clinical Cancer Research Organization
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 S-1 -
- Primary Outcome Measures
Name Time Method Overall survival rate at three years
- Secondary Outcome Measures
Name Time Method Side effect During administration of drug
Trial Locations
- Locations (36)
Nagoya University Hospital
🇯🇵Nagoya, Aichi, Japan
Gunma University Hospital
🇯🇵Maehashi, Gunma, Japan
Hakodate Goryoukaku Hopsital
🇯🇵Hakodate, Hokkaido, Japan
Hyogo Prefectural Awaji Hospital
🇯🇵Sumoto, Hyogo, Japan
Ishikawa Prefectural Central Hospital
🇯🇵Kanazawa, Ishikawa, Japan
Kanazawa Medical University Hospital
🇯🇵Kanazawa, Ishikawa, Japan
Iwate Medical University Hospital
🇯🇵Morioka, Iwate, Japan
Nippon Medical School Second Hospital
🇯🇵Kawasaki, Kanagawa, Japan
St. Marianna University, School of Medicine
🇯🇵Kawasaki, Kanagawa, Japan
Kitazato University East Hospital
🇯🇵Sagamihara, Kanagawa, Japan
Scroll for more (26 remaining)Nagoya University Hospital🇯🇵Nagoya, Aichi, Japan