UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017534 |
|---|---|
| Receipt number | R000020261 |
| Scientific Title | A study of a new device for intra-arterial infusion chemotherapy for head and neck cancer: an external carotid arterial sheath (ECAS) system |
| Date of disclosure of the study information | 2015/05/14 |
| Last modified on | 2017/11/12 11:07:07 |
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Basic information
Public title
A study of a new device for intra-arterial infusion chemotherapy for head and neck cancer: an external carotid arterial sheath (ECAS) system
Acronym
A study of a device for ia chemotherapy for head and neck cancer: ECAS system
Scientific Title
A study of a new device for intra-arterial infusion chemotherapy for head and neck cancer: an external carotid arterial sheath (ECAS) system
Scientific Title:Acronym
A study of a device for ia chemotherapy for head and neck cancer: ECAS system
Region
| Japan |
Condition
Condition
Head and neck cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and usability of ECAS system in patients with head and neck cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Safety
Usability
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 95 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) head and neck cancer
2) histologically confirmed squamous cell carcinoma
3) Performance Statues:0-2(ECOG)
4) WBC:>3,000/mm3 Neutrophyl:>1500/mm3
5) Hemoglobin:>9g/dl
6) AST, ALT:<3.0 times of normal range in each institute
7) sT.bil:<2mg/dl
8) Ccr:>20ml/min
9) written informed consent
Key exclusion criteria
1) severe dysfunction of liver
2) severe dysfunction of kidney
3) history of major allergy to medicine
4) major heart disorders or uncontrolled diabetes mellitus
5) pregnancy or lactation
6) ineligible judged by doctor in charge
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriko Ii |
Organization
Mie University Hospital
Division name
Department of Radiation Oncology
Zip code
Address
2-174, Edobashi, Tsu, Mie
TEL
059-231-5029
ii-n@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriko Ii |
Organization
Mie University Hospital
Division name
Department of Radiation Oncology
Zip code
Address
2-174, Edobashi, Tsu, Mie
TEL
059-231-5029
Homepage URL
ii-n@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Department of Radiology Mie University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
三重大学医学部附属病院（三重県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2014 | Year | 02 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 14 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Clinical lab. test and imaging
Management information
Registered date
| 2015 | Year | 05 | Month | 12 | Day |
Last modified on
| 2017 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020261
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
