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)
Kanazawa Medical University Hospital
🇯🇵Kanazawa, Ishikawa, Japan
St. Marianna University, School of Medicine
🇯🇵Kawasaki, Kanagawa, Japan
Osaka Medical College Hospital
🇯🇵Takatsuki, Osaka, Japan
Surugadai Nihon University Hospital
🇯🇵Chiyoda-ku, Tokyo, Japan
Cancer Institute Hospital
🇯🇵Koto-ku, Tokyo, Japan
Department of surgical oncology and digestive surgery kagoshima university graduate school
🇯🇵Kagoshima, Japan
Nagoya University Hospital
🇯🇵Nagoya, Aichi, Japan
Gunma University Hospital
🇯🇵Maehashi, Gunma, Japan
Hakodate Goryoukaku Hopsital
🇯🇵Hakodate, Hokkaido, Japan
Ishikawa Prefectural Central Hospital
🇯🇵Kanazawa, Ishikawa, Japan
Hyogo Prefectural Awaji Hospital
🇯🇵Sumoto, Hyogo, Japan
Kitazato University East Hospital
🇯🇵Sagamihara, Kanagawa, Japan
Nippon Medical School Second Hospital
🇯🇵Kawasaki, Kanagawa, Japan
Iwate Medical University Hospital
🇯🇵Morioka, Iwate, Japan
Saiseikai Suita Hospital
🇯🇵Suita, Osaka, Japan
Hirakata City Hospital
🇯🇵Hirakata, Osaka, Japan
Jichi Medical School Hospital
🇯🇵Shimono, Tochigi, Japan
Dokkyo University School of Medecine
🇯🇵Shimotsuga, Tochigi, Japan
Yao Municipal Hospital
🇯🇵Yao, Osaka, Japan
Tochigi Cancer Center
🇯🇵Utsunomiya, Tochigi, Japan
Nippon Medical School Tama Nagayama Hospital
🇯🇵Tama, Tokyo, Japan
Tobu Chiiki Hospital
🇯🇵Katsushika-ku, Tokyo, Japan
Keio University Hospital
🇯🇵Shinjuku-ku, Tokyo, Japan
Kouseiren Takaoka Hospital
🇯🇵Takaoka, Toyama, Japan
Tottori University Faculty of Medicine
🇯🇵Yonago, Tottori, Japan
Kanagawa Prefectural Cancer Center
🇯🇵Kanagawa, Yokohama, Japan
Kyusyu University Faculty of Medical Sciences
🇯🇵Fukuoka, Japan
Department of frontier surgery,Draduate school of medicine,Chiba University
🇯🇵Chiba, Japan
Kyusyu Central Hospital of the Mutual Aid Association of Public School Teachers
🇯🇵Fukuoka, Japan
Fukushima Medical University Hospital
🇯🇵Fukushima, Japan
Faculty of Medical and Pharmaceutical Sciences Kumamoto University
🇯🇵Kumamoto, Japan
Osaka City University Graduate School of Medicine
🇯🇵Osaka, Japan
Niigata Prefectural Cancer Center
🇯🇵Niigata, Japan
Osaka Kita Japan Post Hospital
🇯🇵Osaka, Japan
Saga Medical School Faculty of Medicine,Saga University
🇯🇵Saga, Japan
Wakayama Prefectural Medical University Hospital
🇯🇵Wakayama, Japan