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

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 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


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

Value
https://center6.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