Clinical Trial of Chemosensitivity Test
Chemosensitivity Test to Evaluate the Effect of Adjuvant Cancer Chemotherapy (S-1) After Gastric Surgery
2 other identifiers
interventional
300
1 country
36
Brief Summary
To evaluate the usefulness of chemosensitivity test in evaluating the appropriate adjuvant cancer chemotherapy after gastric surgery
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 gastric-cancer
Started Mar 2006
Typical duration for phase_2 gastric-cancer
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2006
CompletedFirst Posted
Study publicly available on registry
February 7, 2006
CompletedStudy Start
First participant enrolled
March 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedJune 29, 2011
June 1, 2011
4.8 years
February 3, 2006
June 28, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival rate
at three years
Secondary Outcomes (1)
Side effect
During administration of drug
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Japan Clinical Cancer Research Organizationlead
- Kitasato Universitycollaborator
Study Sites (36)
Nagoya University Hospital
Nagoya, Aichi-ken, 466-8550, Japan
Department of frontier surgery,Draduate school of medicine,Chiba University
Chiba, Chiba, 260-8670, Japan
Kyusyu University Faculty of Medical Sciences
Fukuoka, Fukuoka, 812-8582, Japan
Kyusyu Central Hospital of the Mutual Aid Association of Public School Teachers
Fukuoka, Fukuoka, 815-8588, Japan
Fukushima Medical University Hospital
Fukushima, Fukushima, 960-1295, Japan
Gunma University Hospital
Maehashi, Gunma, 371-0034, Japan
Hakodate Goryoukaku Hopsital
Hakodate, Hokkaido, 040-0001, Japan
Hyogo Prefectural Awaji Hospital
Sumoto, Hyōgo, 656-0017, Japan
Ishikawa Prefectural Central Hospital
Kanazawa, Ishikawa-ken, 920-8530, Japan
Kanazawa Medical University Hospital
Kanazawa, Ishikawa-ken, 920-8641, Japan
Iwate Medical University Hospital
Morioka, Iwate, 020-8505, Japan
Department of surgical oncology and digestive surgery kagoshima university graduate school
Kagoshima, Kagoshima-ken, 890-8520, Japan
Nippon Medical School Second Hospital
Kawasaki, Kanagawa, 211-8533, Japan
St. Marianna University, School of Medicine
Kawasaki, Kanagawa, 216-8511, Japan
Kitazato University East Hospital
Sagamihara, Kanagawa, 228-8555, Japan
Faculty of Medical and Pharmaceutical Sciences Kumamoto University
Kumamoto, Kumamoto, 860-8556, Japan
Niigata Prefectural Cancer Center
Niigata, Niigata, 951-8566, Japan
Hirakata City Hospital
Hirakata, Osaka, 573-1013, Japan
Osaka Kita Japan Post Hospital
Osaka, Osaka, 530-8798, Japan
Osaka City University Graduate School of Medicine
Osaka, Osaka, 545-8585, Japan
Saiseikai Suita Hospital
Suita, Osaka, 564-0013, Japan
Osaka Medical College Hospital
Takatsuki, Osaka, 569-8686, Japan
Yao Municipal Hospital
Yao, Osaka, 581-0069, Japan
Saga Medical School Faculty of Medicine,Saga University
Saga, Saga-ken, 849-8501, Japan
Jichi Medical School Hospital
Shimono, Tochigi, 329-0498, Japan
Dokkyo University School of Medecine
Shimotsuga, Tochigi, 321-0293, Japan
Tochigi Cancer Center
Utsunomiya, Tochigi, 320-0834, Japan
Surugadai Nihon University Hospital
Chiyoda-ku, Tokyo, 101-8309, Japan
Tobu Chiiki Hospital
Katsushika-ku, Tokyo, 125-8512, Japan
Cancer Institute Hospital
Koto-ku, Tokyo, 135-8550, Japan
Keio University Hospital
Shinjuku-ku, Tokyo, 160-8582, Japan
Nippon Medical School Tama Nagayama Hospital
Tama, Tokyo, 206-8512, Japan
Tottori University Faculty of Medicine
Yonago, Tottori, 683-8504, Japan
Kouseiren Takaoka Hospital
Takaoka, Toyama, 933-8555, Japan
Wakayama Prefectural Medical University Hospital
Wakayama, Wakayama, 641-8510, Japan
Kanagawa Prefectural Cancer Center
Kanagawa, Yokohama, 241-0815, Japan
Related Publications (1)
Tanigawa N, Yamaue H, Ohyama S, Sakuramoto S, Inada T, Kodera Y, Kitagawa Y, Omura K, Terashima M, Sakata Y, Nashimoto A, Yamaguchi T, Chin K, Nomura E, Lee SW, Takeuchi M, Fujii M, Nakajima T. Exploratory phase II trial in a multicenter setting to evaluate the clinical value of a chemosensitivity test in patients with gastric cancer (JACCRO-GC 04, Kubota memorial trial). Gastric Cancer. 2016 Apr;19(2):350-360. doi: 10.1007/s10120-015-0506-z. Epub 2015 Sep 18.
PMID: 26385385DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tetsuro Kubota, Processor
Keio University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 3, 2006
First Posted
February 7, 2006
Study Start
March 1, 2006
Primary Completion
December 1, 2010
Study Completion
March 1, 2011
Last Updated
June 29, 2011
Record last verified: 2011-06