UMIN-CTR Clinical Trial

Basic information
Public title	A clinical trial of intra-arterial infusion chemotherapy with cisplatin for head and neck cancer
Acronym	A clinical trial of intra-arterial infusion chemotherapy with cisplatin for head and neck cancer
Scientific Title	A clinical trial of intra-arterial infusion chemotherapy with cisplatin for head and neck cancer
Scientific Title:Acronym	A clinical trial of intra-arterial infusion chemotherapy with cisplatin for head and neck cancer
Region	Japan

Condition
Condition	Head and neck squamous cell carcinoma
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	In this clinical trial, the maximum tolerrated dose (MTD) will be estimated, based on the dose limiting toxicity of the combination therapy of intra-arterial infusion chemotherapy with cisplatin and radiotherapy for head and neck cancer , and the recommended dose (RD) for the prospective study will be determined.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	maximum tolerrated dose, recommended dose
Key secondary outcomes	response rate, toxicity, overall survival, local control time, progression free time

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	Combined therapy of intra-arterial infusion chemotherapy with cisplatin and radiotherapy
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Head and neck cancer 2)Stage 3, 4A, or 4B 3)Without previous irradiation for head and neck 4)Without previous chemotherapy with cisplatin 5)Squamous cell carcinoma 6)>=20, <=80 7)Performance Status(ECOG) 0-2 8)WBC >3000/mm3, Neutrophil >1500/mm3 9)Hb >9g/dL 10)PLT >=100,000/mm3 11)AST, ALT <3 times the upper limit of normal 12)total bilirubin <2mg/dL 13)Creatinine clearance >50mL/min 14)Provided written informed consent
Key exclusion criteria	1)Prior history of radiotherapy for head and neck 2)History of serious drug allegies 3)With severe complications (hepatic disorder, renal disorder,or heart disease, bowel obstruction, peptic ulcer, severe diabetes) 4)with history of severe mental disorder 5)pregnant or nursing women or women who like be pregnant and men with partner willing to get pregnant 6)Cases that the investigator (subinvestigator) judged as inappropriate as the subject of this clinical study
Target sample size	18

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yoshihito Nomoto
Organization	Mie University Graduate School of Medicine
Division name	Department of Radiation Oncology
Zip code
Address	2-174, Edobashi, Tsu, Mie
TEL	059-231-5029
Email	nomoto-y@clin.medic.mie-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yutaka Toyomasu
Organization	Mie University Hospital
Division name	Department of Radiation Oncology
Zip code
Address	2-174, Edobashi, Tsu, Mie
TEL	059-231-5029
Homepage URL
Email	y-toyomasu@clin.medic.mie-u.ac.jp

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

Funding Source
Organization	Donation for research
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	2015 Year 05 Month 25 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	Terminated
Date of protocol fixation	2015 Year 03 Month 03 Day
Date of IRB
Anticipated trial start date	2015 Year 05 Month 25 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	2015 Year 05 Month 22 Day
Last modified on	2018 Year 03 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020454

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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