UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I/II study of biweekly docetaxel, cisplatin, and S-1 combination neoadjuvant chemotherapy in patients with stage III gastric cancer
Title of the study (Brief title)	Phase I/II study of biweekly docetaxel, cisplatin, and S-1 combination neoadjuvant chemotherapy in patients with stage III gastric cancer
Region	Japan

Condition
Condition	gastric cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To establish neoadjuvant chemotherapy with high safty and usefullness for stage III gastric cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I,II

Assessment
Primary outcomes	Phase I : Feasibility of the regimen followed by decision of recommend dose Phase II : Response rate, Overall survival, Adverse events
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Docetaxel, cisplatin, and S-1 combination neoadjuvant chemotherapy Docetaxel: 20mg/m2 day1,15 CDDP: 25-50mg/m2 day1,15 TS-1: 80mg/m2 day1-7, 15-21
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Histologic confirmation of gastric cancer 2. Stage III with no peritoneal meastases and CY0 by dagnostic laparoscopy 3. Patient expected R0 resection at the registration 4. Performance status (ECOG scale) 0 or 1 5. No prior chemotherapy 6. Adequate baseline organ and marrow function from data within 14 days before registration WBC count >=3,000/mm3,<=12,000/mm3 Neutorophil count>=1,500/mm3 Hemoglobin>=9.0g/dl Platelet count>=100000/mm3 AST,ALT<= 2.5 times the upper limit of normal Al-P<=2.5 times the upper limit of normal Total bilirubin<=1.5 mg/dl serum creatinin level<=1.5 mg/dl Blood urea nitrogen within normal range 7. Patients who can take food orally 8. Provision of written informed consent
Key exclusion criteria	1. with active double cancer within 5 years except intramucosal cancer 2. with a history of severe allergy 3. with active infectious disease(over 38 degrees C) 4. Women in pregnancy, at risk of pregnancy, or hoping to become pregnant. 5. Men who want their partners to become pregnant 6. with a history of cardiac infarction in recent 6 months 7. with a continuous administration of steroids 8. patient who needs continuous administration of Flucytosine, fenitoin or walfarin karium 9. with ulceration on digestive tract and/or bleeding from the ulcer 10. with uncontrollable diarrhea or watery stool 11. with active hepatitis B Ag and/or hepatitis C Ab 12. with serious complication as followings, -Interstitial pneumonia -Pulmonary fibrosis -paralysis on bowel -ischemic heart diseases 13. Any patients judged by the investigator to be unfit to participate in the study
Target sample size	51

Research contact person
Name of lead principal investigator	Chikara Kunisaki
Organization	Yokohama City University Medical Center
Division name	Gastroenterological Center
Address	4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL	045-261-5656
Email	s0714@med.yokohama-cu.ac.jp

Public contact
Name of contact person	Yusuke Izumisawa
Organization	Yokohama City University Medical Center
Division name	Gastroenterological Center
Address	4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL	045-261-5656
Homepage URL
Email	ycu.umin@gmail.com

Sponsor
Institute	Yokohama City University Medical Center
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	横浜市立大学附属市民総合医療センター（神奈川県）

Other administrative information
Date of disclosure of the study information	2013 Year 09 Month 02 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 09 Month 17 Day
Anticipated trial start date	2013 Year 09 Month 02 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 09 Month 02 Day
Last modified on	2017 Year 09 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013599