UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019163 |
|---|---|
| Receipt number | R000022156 |
| Scientific Title | Phase II study evaluating safety of transoral surgery assisted by a flexible-tip rigid endoscope for T1/2 laryngopharyngeal cancer |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2023/04/06 12:47:50 |
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Basic information
Public title
Phase II study evaluating safety of transoral surgery assisted by a flexible-tip rigid endoscope for T1/2 laryngopharyngeal cancer
Acronym
Phase II study evaluating safety of transoral surgery assisted by a flexible-tip rigid endoscope for T1/2 laryngopharyngeal cancer
Scientific Title
Phase II study evaluating safety of transoral surgery assisted by a flexible-tip rigid endoscope for T1/2 laryngopharyngeal cancer
Scientific Title:Acronym
Phase II study evaluating safety of transoral surgery assisted by a flexible-tip rigid endoscope for T1/2 laryngopharyngeal cancer
Region
| Japan |
Condition
Condition
T1/2 laryngopharyngeal squamous cell carcinoma
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of transoral surgery assisted with a flexible tip rigid endoscope for laryngopharyngeal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
postoperative complication rate
assessment day: postoperative day 30
Key secondary outcomes
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
| Device,equipment | Maneuver |
Interventions/Control_1
transoral surgery assisted by a flexible-tip rigid endoscope
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Squamous cell carcinoma is proven by histopathological examination.
2. Primary site is oropharynx, hypopharynx or larynx.
3. T stage is T1 or 2. It is determined by endoscope and image diagnosis(CT or MRI).
4. Tumor is lesser than a half-circle of pharynx.
5. Tumor does not invade nasopharynx, prevertebral fascia, mandible, prerigoid muscles, skull base or carotid artery.
6. Patients do not excluded by clinical N stage.
7. There is no distant metastasis.
8. Patients agree by signing on consent forms.
Key exclusion criteria
non
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Daisuke Nishikawa |
Organization
Aichi Cancer Center Central Hospital
Division name
head and neck surgery
Zip code
Address
1-1 Kanokoden, Chikusa-ku Nagoya, Aichi Japan
TEL
052-761-6111
dsknishi@aichi-cc.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nishikawa Daisuke |
Organization
Aichi Cancer Center Central Hospital
Division name
head and neck surgery
Zip code
Address
1-1 Kanokoden, Chikusa-ku Nagoya, Aichi Japan
TEL
052-761-6111
Homepage URL
dsknishi@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center Central Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
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 | 10 | 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
Completed
Date of protocol fixation
| 2014 | Year | 12 | Month | 22 | Day |
Date of IRB
| 2014 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2014 | Year | 12 | Month | 22 | Day |
Last follow-up date
| 2016 | 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
| 2015 | Year | 09 | Month | 30 | Day |
Last modified on
| 2023 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022156
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
