Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Clinical Trial of Chemosensitivity Test

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Neoplasms
Neoplasms by Site
Stomach Diseases

ClinicalTrials.gov processed this record on November 25, 2014