UMIN-CTR Clinical Trial

Basic information
Public title	Tightening of indication assessments of post-operative radiotherapy for heas and neck carcinoma patients
Acronym	Assessment of post-operative radiotherapy for head and neck carcinoma patients
Scientific Title	Tightening of indication assessments of post-operative radiotherapy for heas and neck carcinoma patients
Scientific Title:Acronym	Assessment of post-operative radiotherapy for head and neck carcinoma patients
Region	Japan

Condition
Condition	Oropharyngeal carcinoma, Hypopharyngeal carcinoma, Laryngeal carcinoma
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The assessment of the possibility to minimaize the indication for post-operative radiotherapy in head and neck carcinoma patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The assessment of the possibility for post-operative radiotherapy in head and neck carcinoma patients as the following two criterias; 1, positive margin at the primary site; 2, extra capsular invasion in the cervical metastatic lymph node.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Surgical margin negative in the primary site and extra-capsular invasion negative in the metastatic lymph node (non-post-oerative radiotherapy group)
Interventions/Control_2	Surgical margin positive in the primary site and/or extra-capsular invasion positeve in the metastatic lymph node (post-operative radiotherapy group)
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	Oropharyngeal carcinoma, hypopharyngeal carcinoma and laryngeal carcinoma patients who will be resected the primary site by minimum invasion surgery with or without neck dissection.
Key exclusion criteria	Refused cases for surgery
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Nobuhiko Oridate
Organization	Yokohama City University School of Medicine
Division name	Otorhinolaryngology, Head and Neck Surgery
Zip code
Address	3-9 Fukuura, Kanazawa-ku, Yokohama
TEL	045-787-2685
Email	noridate@yokohama-cu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Goshi Nishimura
Organization	Yokohama City University School of Medicine
Division name	Otorhinolaryngology, Head and Neck Surgery
Zip code
Address	3-9 Fukuura, Kanazawa-ku, Yokohama
TEL	045-787-2687
Homepage URL
Email	gnishimu@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Hospital
Institute
Department

Funding Source
Organization	Yokohama City University School of Medicine, Department of Otorhinolaryngology, Head and Neck SUrgery
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	横浜市立大学附属病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2014 Year 04 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	Terminated
Date of protocol fixation	2014 Year 03 Month 07 Day
Date of IRB	2014 Year 03 Month 07 Day
Anticipated trial start date	2014 Year 04 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 03 Month 25 Day
Last modified on	2019 Year 09 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015778