UMIN-CTR Clinical Trial

Basic information
Public title	The role of post-operative cetuximab-based bioradiotherapy in high risk head and neck carcinomas.
Acronym	Post-operative bioradiotherapy in high risk head and neck carcinomas
Scientific Title	The role of post-operative cetuximab-based bioradiotherapy in high risk head and neck carcinomas.
Scientific Title:Acronym	Post-operative bioradiotherapy in high risk head and neck carcinomas
Region	Japan

Condition
Condition	Head and neck squamous cell carcinomas
Classification by specialty	Hematology and clinical oncology Oto-rhino-laryngology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the feasibility and efficacy of cetuximab-based bioradiotherapy in post-operative setting.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Completion rate of this treatment Probability of adverse effect
Key secondary outcomes	Overall survival rate Disease free survival rate Loco-regional control rate Probability of distant metastasis

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	Cetuximab-based Bioradiotherapy
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	The cases pathologically diagnosed as squamous cell carcinomas The cases of over than stage 3 The cases with the following risk factors after the surgery 1. tumor cell in surgical margins. 2. Less than 5mm of sugical margin. 3. Extra capsular spread of lymph node metastasis 4. Perineural invasion 5. vessel or ductal invasion, or tumor thrombosis
Key exclusion criteria	The cases with a history of Interstitial pneumonia. The cases with a history of irradiation on head and neck region. The cases that researchers regard as inadequate.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tomohiro Sakashita
Organization	Hokkaido University Graduate school of Medicine.
Division name	Department of Otolaryngology- Head and Neck Surgery.
Zip code
Address	Kita 15, Nishi 7, Kita-ku, Sapporo 060-8638, Japan
TEL	011-707-5958
Email	t-sakashita@med.hokudai.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Tomohiro Sakashita
Organization	Hokkaido University Graduate school of Medicine.
Division name	Department of Otolaryngology- Head and Neck Surgery.
Zip code
Address	Kita 15, Nishi 7, Kita-ku, Sapporo 060-8638, Japan
TEL	011-707-5958
Homepage URL
Email	t-sakashita@med.hokudai.ac.jp

Sponsor
Institute	Department of Otolaryngology- Head and Neck Surgery, Hokkaido University Graduate school of Medicine.
Institute
Department

Funding Source
Organization	Department of Otolaryngology- Head and Neck Surgery, Hokkaido University Graduate school of Medicine.
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
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 20 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	Preinitiation
Date of protocol fixation	2015 Year 04 Month 07 Day
Date of IRB
Anticipated trial start date	2015 Year 07 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry	2023 Year 03 Month 31 Day
Date trial data considered complete	2023 Year 03 Month 31 Day
Date analysis concluded	2023 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2015 Year 05 Month 20 Day
Last modified on	2016 Year 06 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020432

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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