Clinical Trial of Chemosensitivity Test
This study has been completed.
Sponsor:
Japan Clinical Cancer Research Organization
Collaborator:
Kitasato University
Information provided by:
Japan Clinical Cancer Research Organization
ClinicalTrials.gov Identifier:
NCT00287755
First received: February 3, 2006
Last updated: June 28, 2011
Last verified: June 2011
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Purpose
To evaluate the usefulness of chemosensitivity test in evaluating the appropriate adjuvant cancer chemotherapy after gastric surgery
| Condition | Intervention | Phase |
|---|---|---|
|
Gastric Cancer |
Drug: S-1 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Investigator) Primary Purpose: Diagnostic |
| Official Title: | Chemosensitivity Test to Evaluate the Effect of Adjuvant Cancer Chemotherapy (S-1) After Gastric Surgery |
Resource links provided by NLM:
Further study details as provided by Japan Clinical Cancer Research Organization:
Primary Outcome Measures:
- Overall survival rate [ Time Frame: at three years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Side effect [ Time Frame: During administration of drug ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 300 |
| Study Start Date: | March 2006 |
| Study Completion Date: | March 2011 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: S-1
S-1 capsule at a dose of 80 mg/m2 b.i.d. for 4 weeks followed by 2 weeks rest.
|
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.
Eligibility| Ages Eligible for Study: | 20 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00287755
Locations
| Japan | |
| Nagoya University Hospital | |
| Nagoya, Aichi, Japan, 466-8550 | |
| Gunma University Hospital | |
| Maehashi, Gunma, Japan, 371-0034 | |
| Hakodate Goryoukaku Hopsital | |
| Hakodate, Hokkaido, Japan, 040-0001 | |
| Hyogo Prefectural Awaji Hospital | |
| Sumoto, Hyogo, Japan, 656-0017 | |
| Ishikawa Prefectural Central Hospital | |
| Kanazawa, Ishikawa, Japan, 920-8530 | |
| Kanazawa Medical University Hospital | |
| Kanazawa, Ishikawa, Japan, 920-8641 | |
| Iwate Medical University Hospital | |
| Morioka, Iwate, Japan, 020-8505 | |
| Nippon Medical School Second Hospital | |
| Kawasaki, Kanagawa, Japan, 211-8533 | |
| St. Marianna University, School of Medicine | |
| Kawasaki, Kanagawa, Japan, 216-8511 | |
| Kitazato University East Hospital | |
| Sagamihara, Kanagawa, Japan, 228-8555 | |
| Hirakata City Hospital | |
| Hirakata, Osaka, Japan, 573-1013 | |
| Saiseikai Suita Hospital | |
| Suita, Osaka, Japan, 564-0013 | |
| Osaka Medical College Hospital | |
| Takatsuki, Osaka, Japan, 569-8686 | |
| Yao Municipal Hospital | |
| Yao, Osaka, Japan, 581-0069 | |
| Jichi Medical School Hospital | |
| Shimono, Tochigi, Japan, 329-0498 | |
| Dokkyo University School of Medecine | |
| Shimotsuga, Tochigi, Japan, 321-0293 | |
| Tochigi Cancer Center | |
| Utsunomiya, Tochigi, Japan, 320-0834 | |
| Surugadai Nihon University Hospital | |
| Chiyoda-ku, Tokyo, Japan, 101-8309 | |
| Tobu Chiiki Hospital | |
| Katsushika-ku, Tokyo, Japan, 125-8512 | |
| Cancer Institute Hospital | |
| Koto-ku, Tokyo, Japan, 135-8550 | |
| Keio University Hospital | |
| Shinjuku-ku, Tokyo, Japan, 160-8582 | |
| Nippon Medical School Tama Nagayama Hospital | |
| Tama, Tokyo, Japan, 206-8512 | |
| Tottori University Faculty of Medicine | |
| Yonago, Tottori, Japan, 683-8504 | |
| Kouseiren Takaoka Hospital | |
| Takaoka, Toyama, Japan, 933-8555 | |
| Kanagawa Prefectural Cancer Center | |
| Kanagawa, Yokohama, Japan, 241-0815 | |
| Department of frontier surgery,Draduate school of medicine,Chiba University | |
| Chiba, Japan, 260-8670 | |
| Kyusyu Central Hospital of the Mutual Aid Association of Public School Teachers | |
| Fukuoka, Japan, 815-8588 | |
| Kyusyu University Faculty of Medical Sciences | |
| Fukuoka, Japan, 812-8582 | |
| Fukushima Medical University Hospital | |
| Fukushima, Japan, 960-1295 | |
| Department of surgical oncology and digestive surgery kagoshima university graduate school | |
| Kagoshima, Japan, 890-8520 | |
| Faculty of Medical and Pharmaceutical Sciences Kumamoto University | |
| Kumamoto, Japan, 860-8556 | |
| Niigata Prefectural Cancer Center | |
| Niigata, Japan, 951-8566 | |
| Osaka City University Graduate School of Medicine | |
| Osaka, Japan, 545-8585 | |
| Osaka Kita Japan Post Hospital | |
| Osaka, Japan, 530-8798 | |
| Saga Medical School Faculty of Medicine,Saga University | |
| Saga, Japan, 849-8501 | |
| Wakayama Prefectural Medical University Hospital | |
| Wakayama, Japan, 641-8510 | |
Sponsors and Collaborators
Japan Clinical Cancer Research Organization
Kitasato University
Investigators
| Principal Investigator: | Tetsuro Kubota, Processor | Keio University Hospital |
More Information
No publications provided
| Responsible Party: | Tetsurou Kubota / Professor, Center of Comprehensive and Advanced Medicine, Keio University |
| ClinicalTrials.gov Identifier: | NCT00287755 History of Changes |
| Other Study ID Numbers: | JACCRO GC-04, GC-04 |
| Study First Received: | February 3, 2006 |
| Last Updated: | June 28, 2011 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Japan Clinical Cancer Research Organization:
|
gastric cancer S-1 chemosensitivity adjuvant |
Additional relevant MeSH terms:
|
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases |
ClinicalTrials.gov processed this record on May 22, 2013