UMIN-CTR Clinical Trial

Basic information
Public title	Radiation induced Activation of Anti-tumor Immunity for Head and Neck Cancer
Acronym	Radiation induced Immunity for H&N Cancer
Scientific Title	Radiation induced Activation of Anti-tumor Immunity for Head and Neck Cancer
Scientific Title:Acronym	Radiation induced Immunity for H&N Cancer
Region	Japan

Condition
Condition	Head and Neck Cancer
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To clarify the activation mechanism of anti-tumor immunity induced by radiation therapy for head and neck cancer
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. To estimate immune-related factors by measurement substances in blood and histopathological examination for cancer tissues 2. To estimate treatment response and prognosis 3. To summarize treatment outcomes stratified by immune-related factors and clinical characteristics
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	90 years-old >
Gender	Male and Female
Key inclusion criteria	1.Patients giving written informed consent to participate this study 2.Male or female patients aged 20 years or older at the time of diagnosis of head and neck cancers, who are planned for taking radiation therapy or chemo-radiation therapy.
Key exclusion criteria	1.Patients who are regarded as inappropriate to participate in the study by the primary investigators 2.Patients with serious liver dysfunction or renal dysfunction 3.Pregnant or lactating females 4.Patients with clinically significant psychiatric disease that would interfere with participation in this study
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Toshiyasu
Organization	The Cancer Institute Hospital of Japanese Foundation for Cancer Research (JRCR)
Division name	Radiation Oncology Department
Zip code	135-8550
Address	Tokyo Koto-ku Ariake 3-8-31
TEL	03-3520-0111
Email	takashi.toshiyasu@jfcr.or.jp

Public contact
Name of contact person	1st name Takashi Middle name Last name Toshiyasu
Organization	The Cancer Institute Hospital of Japanese Foundation for Cancer Research (JRCR)
Division name	Radiation Oncology Department
Zip code	135-0111
Address	Tokyo Koto-ku Ariake 3-8-31
TEL	03-3520-0111
Homepage URL
Email	takashi.toshiyasu@jfcr.or.jp

Sponsor
Institute	The Cancer Institute Hospital of Japanese Foundation for Cancer Research (JRCR)
Institute
Department

Funding Source
Organization	Toray Industries, Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	The Cancer Institute Hospital of Japanese Foundation for Cancer Research (JRCR)
Address	Tokyo Koto-ku Ariake 3-8-31
Tel	03-3520-0111
Email	takashi.toshiyasu@jfcr.or.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	2018 Year 05 Month 01 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	Open public recruiting
Date of protocol fixation	2018 Year 04 Month 24 Day
Date of IRB	2018 Year 01 Month 09 Day
Anticipated trial start date	2018 Year 05 Month 01 Day
Last follow-up date	2024 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	On-going

Management information
Registered date	2018 Year 04 Month 24 Day
Last modified on	2022 Year 02 Month 02 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036910