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
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 April 21, 2014