Clinical trial NCT00287755: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: gastric cancer
S-1
chemosensitivity
adjuvant
Lead sponsor: Japan Clinical Cancer Research Organization
Sponsor class: OTHER
Collaborators: name: Kitasato University
First posted: 2006-02-07
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Overall survival rate
timeFrame: at three years
Secondary outcomes:
measure: Side effect
timeFrame: During administration of drug
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Nagoya University Hospital
state: Aichi
city: Maehashi
country: Japan
facility: Gunma University Hospital
state: Gunma
city: Hakodate
country: Japan
facility: Hakodate Goryoukaku Hopsital
state: Hokkaido
city: Sumoto
country: Japan
facility: Hyogo Prefectural Awaji Hospital
state: Hyogo
city: Kanazawa
country: Japan
facility: Ishikawa Prefectural Central Hospital
state: Ishikawa
city: Kanazawa
country: Japan
facility: Kanazawa Medical University Hospital
state: Ishikawa
city: Morioka
country: Japan
facility: Iwate Medical University Hospital
state: Iwate
city: Kawasaki
country: Japan
facility: Nippon Medical School Second Hospital
state: Kanagawa
city: Kawasaki
country: Japan
facility: St. Marianna University, School of Medicine
state: Kanagawa
city: Sagamihara
country: Japan
facility: Kitazato University East Hospital
state: Kanagawa
city: Hirakata
country: Japan
facility: Hirakata City Hospital
state: Osaka
city: Suita
country: Japan
facility: Saiseikai Suita Hospital
state: Osaka
city: Takatsuki
country: Japan
facility: Osaka Medical College Hospital
state: Osaka
city: Yao
country: Japan
facility: Yao Municipal Hospital
state: Osaka
city: Shimono
country: Japan
facility: Jichi Medical School Hospital
state: Tochigi
city: Shimotsuga
country: Japan
facility: Dokkyo University School of Medecine
state: Tochigi
city: Utsunomiya
country: Japan
facility: Tochigi Cancer Center
state: Tochigi
city: Chiyoda-ku
country: Japan
facility: Surugadai Nihon University Hospital
state: Tokyo
city: Katsushika-ku
country: Japan
facility: Tobu Chiiki Hospital
state: Tokyo
city: Koto-ku
country: Japan
facility: Cancer Institute Hospital
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Keio University Hospital
state: Tokyo
city: Tama
country: Japan
facility: Nippon Medical School Tama Nagayama Hospital
state: Tokyo
city: Yonago
country: Japan
facility: Tottori University Faculty of Medicine
state: Tottori
city: Takaoka
country: Japan
facility: Kouseiren Takaoka Hospital
state: Toyama
city: Kanagawa
country: Japan
facility: Kanagawa Prefectural Cancer Center
state: Yokohama
city: Chiba
country: Japan
facility: Department of frontier surgery,Draduate school of medicine,Chiba University
city: Fukuoka
country: Japan
facility: Kyusyu University Faculty of Medical Sciences
city: Fukuoka
country: Japan
facility: Kyusyu Central Hospital of the Mutual Aid Association of Public School Teachers
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital
city: Kagoshima
country: Japan
facility: Department of surgical oncology and digestive surgery kagoshima university graduate school
city: Kumamoto
country: Japan
facility: Faculty of Medical and Pharmaceutical Sciences Kumamoto University
city: Niigata
country: Japan
facility: Niigata Prefectural Cancer Center
city: Osaka
country: Japan
facility: Osaka Kita Japan Post Hospital
city: Osaka
country: Japan
facility: Osaka City University Graduate School of Medicine
city: Saga
country: Japan
facility: Saga Medical School Faculty of Medicine,Saga University
city: Wakayama
country: Japan
facility: Wakayama Prefectural Medical University Hospital
Study officials:
affiliation: Keio University Hospital
name: Tetsuro Kubota, Processor
role: PRINCIPAL_INVESTIGATOR
References:
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.