Clinical Trial of Chemosensitivity Test

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00287755
• Other study ID #: JACCRO GC-04
• Secondary ID: GC-04
• Status: Completed
• Phase: Phase 2
• First received: February 3, 2006
• Last updated: June 28, 2011
• Start date: March 2006
• Est. completion date: March 2011

Study information

• Verified date: June 2011
• Source: Japan Clinical Cancer Research Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• S-1
S-1 capsule at a dose of 80 mg/m2 b.i.d. for 4 weeks followed by 2 weeks rest.

Locations

Country	Name	City	State
Japan	Department of frontier surgery,Draduate school of medicine,Chiba University	Chiba
Japan	Surugadai Nihon University Hospital	Chiyoda-ku	Tokyo
Japan	Kyusyu Central Hospital of the Mutual Aid Association of Public School Teachers	Fukuoka
Japan	Kyusyu University Faculty of Medical Sciences	Fukuoka
Japan	Fukushima Medical University Hospital	Fukushima
Japan	Hakodate Goryoukaku Hopsital	Hakodate	Hokkaido
Japan	Hirakata City Hospital	Hirakata	Osaka
Japan	Department of surgical oncology and digestive surgery kagoshima university graduate school	Kagoshima
Japan	Kanagawa Prefectural Cancer Center	Kanagawa	Yokohama
Japan	Ishikawa Prefectural Central Hospital	Kanazawa	Ishikawa
Japan	Kanazawa Medical University Hospital	Kanazawa	Ishikawa
Japan	Tobu Chiiki Hospital	Katsushika-ku	Tokyo
Japan	Nippon Medical School Second Hospital	Kawasaki	Kanagawa
Japan	St. Marianna University, School of Medicine	Kawasaki	Kanagawa
Japan	Cancer Institute Hospital	Koto-ku	Tokyo
Japan	Faculty of Medical and Pharmaceutical Sciences Kumamoto University	Kumamoto
Japan	Gunma University Hospital	Maehashi	Gunma
Japan	Iwate Medical University Hospital	Morioka	Iwate
Japan	Nagoya University Hospital	Nagoya	Aichi
Japan	Niigata Prefectural Cancer Center	Niigata
Japan	Osaka City University Graduate School of Medicine	Osaka
Japan	Osaka Kita Japan Post Hospital	Osaka
Japan	Saga Medical School Faculty of Medicine,Saga University	Saga
Japan	Kitazato University East Hospital	Sagamihara	Kanagawa
Japan	Jichi Medical School Hospital	Shimono	Tochigi
Japan	Dokkyo University School of Medecine	Shimotsuga	Tochigi
Japan	Keio University Hospital	Shinjuku-ku	Tokyo
Japan	Saiseikai Suita Hospital	Suita	Osaka
Japan	Hyogo Prefectural Awaji Hospital	Sumoto	Hyogo
Japan	Kouseiren Takaoka Hospital	Takaoka	Toyama
Japan	Osaka Medical College Hospital	Takatsuki	Osaka
Japan	Nippon Medical School Tama Nagayama Hospital	Tama	Tokyo
Japan	Tochigi Cancer Center	Utsunomiya	Tochigi
Japan	Wakayama Prefectural Medical University Hospital	Wakayama
Japan	Yao Municipal Hospital	Yao	Osaka
Japan	Tottori University Faculty of Medicine	Yonago	Tottori

Sponsors (2)

Lead Sponsor	Collaborator
Japan Clinical Cancer Research Organization	Kitasato University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival rate		at three years	No
Secondary	Side effect		During administration of drug	Yes