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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030212
Receipt No. R000034495
Scientific Title Single-center prospective cohort study of carotid-sparing intensity-modulated radiotherapy in early glottis cancer
Date of disclosure of the study information 2017/12/04
Last modified on 2019/06/04

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Basic information
Public title Single-center prospective cohort study of carotid-sparing intensity-modulated radiotherapy in early glottis cancer
Acronym Carotid-sparing intensity-modulated radiotherapy in early glottis cancer
Scientific Title Single-center prospective cohort study of carotid-sparing intensity-modulated radiotherapy in early glottis cancer
Scientific Title:Acronym Carotid-sparing intensity-modulated radiotherapy in early glottis cancer
Region
Japan

Condition
Condition Early glottis cancer
Classification by specialty
Oto-rhino-laryngology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify validity for carotid artery sclerosis by carotid-sparing intensity-modulated radiotherapy in early glottis cancer
To clarify safety for intensity-modulated radiotherapy in early glottis cancer by local control rate
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Carotid intima-media thickness after radiotherapy 1,2 years later
Key secondary outcomes Local control rate after radiotherapy 1,2 years later

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 (Interventions)
Patients who receive carotid-sparing (max dose<35Gy) intensity-modulated radiotherapy in early glottis cancer
Interventions/Control_2 (Control)
Patients with head and neck cancer who receive radiotherapy (more than 50Gy) without carotid-saprinig
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 (Interventions)
Patients with glottis cancer who meet all of the following criteria;
1.Clinical T1 or T2 (UICC ver.7) glottis cancer diagnosed by laryngeal endoscope and CT or MRI
2.Pathologically confirmed squamous cell cancer
3.Clinical N0 and M0 diagnosed by neck CT and chest Xp (chest CT)
4.Age over 20
5.Performance status (ECOG) 0-2
6.No prior surgery or radiotherapy against neck
7.Written informed consent

(Control)
Patients with head and neck cancer who meet all of the following criteria;
1.Age over 20
2.Pathologically confirmed head and neck cancer
3.Will receive radiotherapy more than 50Gy
4.Performance status (ECOG) 0-2
5.Written informed consent
Key exclusion criteria (Interventions/control)
1.Patients have psychiatric disorders that may comprise the patient's ability to receive radiotherapy
2.Patients who is considered ineligible for enrolling the study by a principal investigator or sub-investigator
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Sasai
Middle name
Last name Keisuke
Organization Juntendo University
Division name Department of Radiation Oncology
Zip code 113-8431
Address Tokyo
TEL +81338133111
Email ykosugi@juntendo.ac.jp

Public contact
Name of contact person
1st name Kosugi
Middle name
Last name Yasuo
Organization Juntendo University
Division name Department of Radiation Oncology
Zip code 113-8431
Address Tokyo
TEL +81338133111
Homepage URL
Email ykosugi@juntendo.ac.jp

Sponsor
Institute Juntendo University, Graduate School of Medicine, Department of Radiation Oncology
Institute
Department

Funding Source
Organization Juntendo University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization Juntendo Clinical Research and Trial Center
Address 2-1-1 hongo,Bunkyo,Tokyo
Tel 03-3813-3111
Email kenkyu58585@juntendo.ac.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
2017 Year 12 Month 04 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
2017 Year 10 Month 26 Day
Date of IRB
2017 Year 11 Month 24 Day
Anticipated trial start date
2017 Year 12 Month 01 Day
Last follow-up date
2021 Year 12 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
2017 Year 12 Month 01 Day
Last modified on
2019 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034495

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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