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Clinical Trial of Chemosensitivity Test

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
S-1
Sponsored by
Japan Clinical Cancer Research Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastric Cancer focused on measuring gastric cancer, S-1, chemosensitivity, adjuvant

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Nagoya University Hospital
  • Gunma University Hospital
  • Hakodate Goryoukaku Hopsital
  • Hyogo Prefectural Awaji Hospital
  • Ishikawa Prefectural Central Hospital
  • Kanazawa Medical University Hospital
  • Iwate Medical University Hospital
  • Nippon Medical School Second Hospital
  • St. Marianna University, School of Medicine
  • Kitazato University East Hospital
  • Hirakata City Hospital
  • Saiseikai Suita Hospital
  • Osaka Medical College Hospital
  • Yao Municipal Hospital
  • Jichi Medical School Hospital
  • Dokkyo University School of Medecine
  • Tochigi Cancer Center
  • Surugadai Nihon University Hospital
  • Tobu Chiiki Hospital
  • Cancer Institute Hospital
  • Keio University Hospital
  • Nippon Medical School Tama Nagayama Hospital
  • Tottori University Faculty of Medicine
  • Kouseiren Takaoka Hospital
  • Kanagawa Prefectural Cancer Center
  • Department of frontier surgery,Draduate school of medicine,Chiba University
  • Kyusyu University Faculty of Medical Sciences
  • Kyusyu Central Hospital of the Mutual Aid Association of Public School Teachers
  • Fukushima Medical University Hospital
  • Department of surgical oncology and digestive surgery kagoshima university graduate school
  • Faculty of Medical and Pharmaceutical Sciences Kumamoto University
  • Niigata Prefectural Cancer Center
  • Osaka Kita Japan Post Hospital
  • Osaka City University Graduate School of Medicine
  • Saga Medical School Faculty of Medicine,Saga University
  • Wakayama Prefectural Medical University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Overall survival rate

Secondary Outcome Measures

Side effect

Full Information

First Posted
February 3, 2006
Last Updated
June 28, 2011
Sponsor
Japan Clinical Cancer Research Organization
Collaborators
Kitasato University
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1. Study Identification

Unique Protocol Identification Number
NCT00287755
Brief Title
Clinical Trial of Chemosensitivity Test
Official Title
Chemosensitivity Test to Evaluate the Effect of Adjuvant Cancer Chemotherapy (S-1) After Gastric Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Japan Clinical Cancer Research Organization
Collaborators
Kitasato University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer
Keywords
gastric cancer, S-1, chemosensitivity, adjuvant

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
S-1
Intervention Description
S-1 capsule at a dose of 80 mg/m2 b.i.d. for 4 weeks followed by 2 weeks rest.
Primary Outcome Measure Information:
Title
Overall survival rate
Time Frame
at three years
Secondary Outcome Measure Information:
Title
Side effect
Time Frame
During administration of drug

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tetsuro Kubota, Processor
Organizational Affiliation
Keio University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nagoya University Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
466-8550
Country
Japan
Facility Name
Gunma University Hospital
City
Maehashi
State/Province
Gunma
ZIP/Postal Code
371-0034
Country
Japan
Facility Name
Hakodate Goryoukaku Hopsital
City
Hakodate
State/Province
Hokkaido
ZIP/Postal Code
040-0001
Country
Japan
Facility Name
Hyogo Prefectural Awaji Hospital
City
Sumoto
State/Province
Hyogo
ZIP/Postal Code
656-0017
Country
Japan
Facility Name
Ishikawa Prefectural Central Hospital
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8530
Country
Japan
Facility Name
Kanazawa Medical University Hospital
City
Kanazawa
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Facility Name
Iwate Medical University Hospital
City
Morioka
State/Province
Iwate
ZIP/Postal Code
020-8505
Country
Japan
Facility Name
Nippon Medical School Second Hospital
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
211-8533
Country
Japan
Facility Name
St. Marianna University, School of Medicine
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
Facility Name
Kitazato University East Hospital
City
Sagamihara
State/Province
Kanagawa
ZIP/Postal Code
228-8555
Country
Japan
Facility Name
Hirakata City Hospital
City
Hirakata
State/Province
Osaka
ZIP/Postal Code
573-1013
Country
Japan
Facility Name
Saiseikai Suita Hospital
City
Suita
State/Province
Osaka
ZIP/Postal Code
564-0013
Country
Japan
Facility Name
Osaka Medical College Hospital
City
Takatsuki
State/Province
Osaka
ZIP/Postal Code
569-8686
Country
Japan
Facility Name
Yao Municipal Hospital
City
Yao
State/Province
Osaka
ZIP/Postal Code
581-0069
Country
Japan
Facility Name
Jichi Medical School Hospital
City
Shimono
State/Province
Tochigi
ZIP/Postal Code
329-0498
Country
Japan
Facility Name
Dokkyo University School of Medecine
City
Shimotsuga
State/Province
Tochigi
ZIP/Postal Code
321-0293
Country
Japan
Facility Name
Tochigi Cancer Center
City
Utsunomiya
State/Province
Tochigi
ZIP/Postal Code
320-0834
Country
Japan
Facility Name
Surugadai Nihon University Hospital
City
Chiyoda-ku
State/Province
Tokyo
ZIP/Postal Code
101-8309
Country
Japan
Facility Name
Tobu Chiiki Hospital
City
Katsushika-ku
State/Province
Tokyo
ZIP/Postal Code
125-8512
Country
Japan
Facility Name
Cancer Institute Hospital
City
Koto-ku
State/Province
Tokyo
ZIP/Postal Code
135-8550
Country
Japan
Facility Name
Keio University Hospital
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Nippon Medical School Tama Nagayama Hospital
City
Tama
State/Province
Tokyo
ZIP/Postal Code
206-8512
Country
Japan
Facility Name
Tottori University Faculty of Medicine
City
Yonago
State/Province
Tottori
ZIP/Postal Code
683-8504
Country
Japan
Facility Name
Kouseiren Takaoka Hospital
City
Takaoka
State/Province
Toyama
ZIP/Postal Code
933-8555
Country
Japan
Facility Name
Kanagawa Prefectural Cancer Center
City
Kanagawa
State/Province
Yokohama
ZIP/Postal Code
241-0815
Country
Japan
Facility Name
Department of frontier surgery,Draduate school of medicine,Chiba University
City
Chiba
ZIP/Postal Code
260-8670
Country
Japan
Facility Name
Kyusyu University Faculty of Medical Sciences
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Kyusyu Central Hospital of the Mutual Aid Association of Public School Teachers
City
Fukuoka
ZIP/Postal Code
815-8588
Country
Japan
Facility Name
Fukushima Medical University Hospital
City
Fukushima
ZIP/Postal Code
960-1295
Country
Japan
Facility Name
Department of surgical oncology and digestive surgery kagoshima university graduate school
City
Kagoshima
ZIP/Postal Code
890-8520
Country
Japan
Facility Name
Faculty of Medical and Pharmaceutical Sciences Kumamoto University
City
Kumamoto
ZIP/Postal Code
860-8556
Country
Japan
Facility Name
Niigata Prefectural Cancer Center
City
Niigata
ZIP/Postal Code
951-8566
Country
Japan
Facility Name
Osaka Kita Japan Post Hospital
City
Osaka
ZIP/Postal Code
530-8798
Country
Japan
Facility Name
Osaka City University Graduate School of Medicine
City
Osaka
ZIP/Postal Code
545-8585
Country
Japan
Facility Name
Saga Medical School Faculty of Medicine,Saga University
City
Saga
ZIP/Postal Code
849-8501
Country
Japan
Facility Name
Wakayama Prefectural Medical University Hospital
City
Wakayama
ZIP/Postal Code
641-8510
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
26385385
Citation
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.
Results Reference
derived

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Clinical Trial of Chemosensitivity Test

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