UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study of a new device for intra-arterial infusion chemotherapy for head and neck cancer: an external carotid arterial sheath (ECAS) system
Title of the study (Brief title)	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	Noriko Ii
Organization	Mie University Hospital
Division name	Department of Radiation Oncology
Address	2-174, Edobashi, Tsu, Mie
TEL	059-231-5029
Email	ii-n@clin.medic.mie-u.ac.jp

Public contact
Name of contact person	Noriko Ii
Organization	Mie University Hospital
Division name	Department of Radiation Oncology
Address	2-174, Edobashi, Tsu, Mie
TEL	059-231-5029
Homepage URL
Email	ii-n@clin.medic.mie-u.ac.jp

Sponsor
Institute	Department of Radiology Mie University Graduate School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 02 Month 14 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020261