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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000015632
Receipt No. R000018093
Scientific Title Neo adjuvant chemotherapy by Docetaxel + S-1 for resentable gasric cabcer
Date of disclosure of the study information 2014/11/07
Last modified on 2017/02/15

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Basic information
Public title Neo adjuvant chemotherapy by Docetaxel + S-1 for resentable gasric cabcer
Acronym NAC DS
Scientific Title Neo adjuvant chemotherapy by Docetaxel + S-1 for resentable gasric cabcer
Scientific Title:Acronym 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
1st name
Middle name
Last name Hisahiro Matsubara
Organization Graduate school of Medicine, Chiba University
Division name Frontier Surgery
Zip code
Address 1-8-1, Inohan, Chuo-ku, Chiba
TEL 043-226-2110
Email naohana718@faculty.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoyuki Hanari
Organization Graduate school of Medicine, Chiba University
Division name Frontier Surgery
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2012 Year 05 Month 27 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000018093

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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