UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Neo adjuvant chemotherapy by Docetaxel + S-1 for resentable gasric cabcer
Title of the study (Brief title)	NAC DS
Region	Japan

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

Objectives
Narrative objectives1	Safety of the neo adjubant chemotherapy by Docetaxel plus Tgafur-Gimeracil-Oteracil for gastric cancer
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	feasibility
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	Neo adjuvant chemotherapy
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1. adenocarcinoma 2. radical operation is possible by protcol operation 3. Stage IIB, IIIA, IIIB, IIIC patients except for distant metastasis 4. 20 < age <75 5. No preoperative treatment, such as radiotherapy, chemotherapy and hormone therapy 6. ingestionable patient 7. PS 0-1 8. without seriou complication 9. patient with consent
Key exclusion criteria	1. Active double cancer. 2. Administration contraindication of TS-1 3. Continuous use of flucytosine, phenytoin or warfarin potassium 4. History of severe drug allergy (over grade 3) 5. Severe complications 6. infection or acute infectious disease 7. HBV or HCV positive 8. Severe watery diarrhea 9. Female who are pregnant, nursing, suspected of being pregnant or hope to become pregnant during the study period. 10. No birth-control 11. Psychosis or Psychiatric disorder 12. Sever edema to treat 13. History of severe peripheral nerve disorder (over grade 2) 14. HIV positive 15. Patients judged inappropriate for the study by their physicians
Target sample size	20

Research contact person
Name of lead principal investigator	Hisahiro Matsubara
Organization	Graduate school of Medicine, Chiba University
Division name	Frontier Surgery
Address	1-8-1, Inohan, Chuo-ku, Chiba
TEL	043-226-2110
Email	naohana718@faculty.chiba-u.jp

Public contact
Name of contact person	Naoyuki Hanari
Organization	Graduate school of Medicine, Chiba University
Division name	Frontier Surgery
Address	1-8-1, Inohan, Chuo-ku, Chiba
TEL	043-226-2110
Homepage URL
Email	naohana718@faculty.chiba-u.jp

Sponsor
Institute	Department of Frontier Surgery, Graduate school of Medicine, Chiba University
Institute
Department

Funding Source
Organization	Department of Frontier Surgery, Graduate school of Medicine, Chiba University
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2014 Year 11 Month 07 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2012 Year 05 Month 27 Day
Anticipated trial start date	2012 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2014 Year 11 Month 07 Day
Last modified on	2017 Year 02 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018093