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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000017634
Receipt No. R000020432
Scientific Title The role of post-operative cetuximab-based bioradiotherapy in high risk head and neck carcinomas.
Date of disclosure of the study information 2015/05/20
Last modified on 2016/06/27

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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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