Clinical Trial of Chemosensitivity Test

June 28, 2011 updated by: Japan Clinical Cancer Research Organization

Chemosensitivity Test to Evaluate the Effect of Adjuvant Cancer Chemotherapy (S-1) After Gastric Surgery

To evaluate the usefulness of chemosensitivity test in evaluating the appropriate adjuvant cancer chemotherapy after gastric surgery

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chiba, Japan, 260-8670
        • Department of frontier surgery,Draduate school of medicine,Chiba University
      • Fukuoka, Japan, 812-8582
        • Kyusyu University Faculty of Medical Sciences
      • Fukuoka, Japan, 815-8588
        • Kyusyu Central Hospital of the Mutual Aid Association of Public School Teachers
      • Fukushima, Japan, 960-1295
        • Fukushima Medical University Hospital
      • Kagoshima, Japan, 890-8520
        • Department of surgical oncology and digestive surgery kagoshima university graduate school
      • Kumamoto, Japan, 860-8556
        • Faculty of Medical and Pharmaceutical Sciences Kumamoto University
      • Niigata, Japan, 951-8566
        • Niigata Prefectural Cancer Center
      • Osaka, Japan, 545-8585
        • Osaka City University Graduate School of Medicine
      • Osaka, Japan, 530-8798
        • Osaka Kita Japan Post Hospital
      • Saga, Japan, 849-8501
        • Saga Medical School Faculty of Medicine,Saga University
      • Wakayama, Japan, 641-8510
        • Wakayama Prefectural Medical University Hospital
    • Aichi
      • Nagoya, Aichi, Japan, 466-8550
        • Nagoya University Hospital
    • Gunma
      • Maehashi, Gunma, Japan, 371-0034
        • Gunma University Hospital
    • Hokkaido
      • Hakodate, Hokkaido, Japan, 040-0001
        • Hakodate Goryoukaku Hopsital
    • Hyogo
      • Sumoto, Hyogo, Japan, 656-0017
        • Hyogo Prefectural Awaji Hospital
    • Ishikawa
      • Kanazawa, Ishikawa, Japan, 920-8530
        • Ishikawa Prefectural Central Hospital
      • Kanazawa, Ishikawa, Japan, 920-8641
        • Kanazawa Medical University Hospital
    • Iwate
      • Morioka, Iwate, Japan, 020-8505
        • Iwate Medical University Hospital
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 211-8533
        • Nippon Medical School Second Hospital
      • Kawasaki, Kanagawa, Japan, 216-8511
        • St. Marianna University, School of Medicine
      • Sagamihara, Kanagawa, Japan, 228-8555
        • Kitazato University East Hospital
    • Osaka
      • Hirakata, Osaka, Japan, 573-1013
        • Hirakata City Hospital
      • Suita, Osaka, Japan, 564-0013
        • Saiseikai Suita Hospital
      • Takatsuki, Osaka, Japan, 569-8686
        • Osaka Medical College Hospital
      • Yao, Osaka, Japan, 581-0069
        • Yao Municipal Hospital
    • Tochigi
      • Shimono, Tochigi, Japan, 329-0498
        • Jichi Medical School Hospital
      • Shimotsuga, Tochigi, Japan, 321-0293
        • Dokkyo University School of Medecine
      • Utsunomiya, Tochigi, Japan, 320-0834
        • Tochigi Cancer Center
    • Tokyo
      • Chiyoda-ku, Tokyo, Japan, 101-8309
        • Surugadai Nihon university hospital
      • Katsushika-ku, Tokyo, Japan, 125-8512
        • Tobu Chiiki Hospital
      • Koto-ku, Tokyo, Japan, 135-8550
        • Cancer Institute Hospital
      • Shinjuku-ku, Tokyo, Japan, 160-8582
        • Keio University Hospital
      • Tama, Tokyo, Japan, 206-8512
        • Nippon Medical School Tama Nagayama Hospital
    • Tottori
      • Yonago, Tottori, Japan, 683-8504
        • Tottori University Faculty of Medicine
    • Toyama
      • Takaoka, Toyama, Japan, 933-8555
        • Kouseiren Takaoka Hospital
    • Yokohama
      • Kanagawa, Yokohama, Japan, 241-0815
        • Kanagawa Prefectural Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall survival rate
Time Frame: at three years
at three years

Secondary Outcome Measures

Outcome Measure
Time Frame
Side effect
Time Frame: During administration of drug
During administration of drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Japan Clinical Cancer Research Organization

Collaborators

Kitasato University

Investigators

  • Principal Investigator: Tetsuro Kubota, Processor, Keio University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)

March 1, 2011

Study Registration Dates

First Submitted

February 3, 2006

First Submitted That Met QC Criteria

February 3, 2006

First Posted (ESTIMATE)

February 7, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

June 29, 2011

Last Update Submitted That Met QC Criteria

June 28, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JACCRO GC-04
  • GC-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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