UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015632 |
|---|---|
| Receipt number | 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 13:56:42 |
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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
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
naohana718@faculty.chiba-u.jp
Sponsor or person
Institute
Department of Frontier Surgery, Graduate school of Medicine, Chiba University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018093
