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Name
UMIN ID

Recruitment status Terminated
Unique ID issued by UMIN UMIN000013504
Receipt No. R000015778
Scientific Title Tightening of indication assessments of post-operative radiotherapy for heas and neck carcinoma patients
Date of disclosure of the study information 2014/04/01
Last modified on 2019/09/30

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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://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015778

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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