UMIN-CTR Clinical Trial

Basic information
Public title	The study to examine the appropriate skin dose in intensity modulated radiotherapy with cetuximab
Acronym	The study to examine the appropriate skin dose in intensity modulated radiotherapy with cetuximab
Scientific Title	The study to examine the appropriate skin dose in intensity modulated radiotherapy with cetuximab
Scientific Title:Acronym	The study to examine the appropriate skin dose in intensity modulated radiotherapy with cetuximab
Region	Japan

Condition
Condition	Head and neck cancer
Classification by specialty	Hematology and clinical oncology Oto-rhino-laryngology Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To examine the appropriate skin dose with skin clip in intensity modulated radiotherapy with conccurent use of cetuximab and to evaluate the efficacy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I,II

Assessment
Primary outcomes	Phase I: Acute skin toxicity Phase II: Response rate(at the 8 weeks after radiotherapy)
Key secondary outcomes	Locoregional progression free survival Progression free survival Overall survival Adverse events

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Other
Interventions/Control_1	Intensity modulated radiotherapy (more than 60 Gy) with concurrent use of cetuximab
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Locally advanced head and neck carcinoma Concurrent use of cetuximab Intensity modulated radiotherapy The number of lymph node region irradiated is equal to or more than 2 Age over 20 PS 0-2 Written informed consent
Key exclusion criteria	Severe coexisting disease Synchronous malignancies Pregnancy, possible pregnancy
Target sample size	39

Research contact person
Name of lead principal investigator	1st name Jun Middle name Last name Itami
Organization	National Cancer Center Hospital, Japan
Division name	Department of Radiation Oncology
Zip code	1040045
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL	03-3542-2511
Email	jitami@ncc.go.jp

Public contact
Name of contact person	1st name Koji Middle name Last name Inaba
Organization	National Cancer Center Hospital, Japan
Division name	Department of Radiation Oncology
Zip code	1040045
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL	03-3542-2511
Homepage URL
Email	koinaba@ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital, Japan
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Cancer Center Institutional Review Board
Address	5-1-1 Tsukiji, Chuo-ku Tokyo, 104-0045 Japan
Tel	03-3542-2511
Email	NCC_IRBoffice@ml.res.ncc.go.jp

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 11 Month 10 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	Completed
Date of protocol fixation	2015 Year 10 Month 16 Day
Date of IRB	2015 Year 10 Month 16 Day
Anticipated trial start date	2015 Year 11 Month 10 Day
Last follow-up date	2020 Year 10 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 11 Month 09 Day
Last modified on	2021 Year 05 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022735