UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012149 |
|---|---|
| Receipt number | R000014203 |
| Scientific Title | Muti instuitutional clinical study of transoral robotic surgery for laryngopharyngeal cancer |
| Date of disclosure of the study information | 2013/10/28 |
| Last modified on | 2016/04/06 22:05:45 |
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Basic information
Public title
Muti instuitutional clinical study of transoral
robotic surgery for laryngopharyngeal cancer
Acronym
Transoral robotic sugery for laryngopharyngeal
cancer
Scientific Title
Muti instuitutional clinical study of transoral
robotic surgery for laryngopharyngeal cancer
Scientific Title:Acronym
Transoral robotic sugery for laryngopharyngeal
cancer
Region
| Japan |
Condition
Condition
Laryngopharyngeal cancer
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of
transoral robotic surgery for laryngopharyngeal
cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Positive surgical margin rate
NG tube or PEG dependency rate
Key secondary outcomes
Completion rate of surgery, hospitalzation
period,
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 |
Interventions/Control_1
Transoral robotic surgery
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Single cancer lesion in mesopharynx,
hypopharynx, or larynx
2) Diagnosed as squamous cell carcinoma
3) Fultill the following conditions regarding
TNM
a)Tis, T1, or T2 cancer
b)N0 or non extracapsule invation N(+) after
neck dissection more than 10 days prior to
registration
c)M0
4) Primary lesion has no adhesion with
neiboring tissue and is movable
5) ECOG PS is 0, 1, or 2
6) Fulfill the following condition within 4 weeks
prior to registration date
Hb more than 8 g/dL
Plt more than 50000/uL
AST less than 120 IU/L
ALT less than 120 IU/L
Cre less than 1.5mg/dL
7) Obtained consent form from the candidate
Key exclusion criteria
1) No tristmus
2) Having the following condition of diseases
Synchronistic active cancer lesion
Radiation history for the treated site
3) Metachronistric invasive cancer of
laryngopharynx in the same sublesion of the
same side.
4) Having the following diseases:
Severe cardiovascular and/or respiratory
disease
Uncontroled DM
5) Pregnant women and possible pregnant
women
6) Patients whom attending doctor consider to
be inappropriate to attend the study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ichiro Tateya |
Organization
Kyoto University
Division name
Otolaryngology-Head & Neck Surgery
Zip code
Address
Sakyo-ku Kyoto 606-8507 Japan
TEL
075-751-3346
tateya@ent.kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshinori Murayama |
Organization
Kyoto University
Division name
Instititute for Advancement of Clinical and Translational Science
Zip code
Address
Sakyo-ku, Kyoto, 606-8507 Japan
TEL
075-751-4739
Homepage URL
murayama@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
MHLW
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tottori University
Tokyo Medical University
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
京都大学医学部附属病院（京都府）
東京医科大学附属病院（東京都）
鳥取大学医学部附属病院（鳥取県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 28 | 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
| 2015 | Year | 01 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 31 | Day |
Other
Other related information
Following instruments are used for this clinical study. These instruments have not been approved by PMDA for laryngo-pharyngeal surgery.
# Medical devices
da Vinci Surgical System (IS2000)
da Vinci Si Surgical System (IS3000)
5mm Monopolar Cautery(420142)
Needle Driver(420117)
5mm Maryland Dissector(420143)
5mm Flared Cannula(420262)
# Disposable materials
Cautery Spatula Tip(400160)
Management information
Registered date
| 2013 | Year | 10 | Month | 28 | Day |
Last modified on
| 2016 | 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=R000014203
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
