UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030212 |
|---|---|
| Receipt number | 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 12:13:08 |
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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
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
ykosugi@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University, Graduate School of Medicine, Department of Radiation Oncology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034495
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