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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000012139
Receipt No. R000014195
Scientific Title Muti instuitutional clinical study of transoral robotic surgery for laryngopharyngeal cancer - a pilot study -
Date of disclosure of the study information 2013/10/28
Last modified on 2016/02/05

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Basic information
Public title Muti instuitutional clinical study of transoral robotic surgery for laryngopharyngeal cancer - a pilot study -
Acronym Transoral robotic sugery for laryngopharyngeal cancer - a pilot study -
Scientific Title Muti instuitutional clinical study of transoral robotic surgery for laryngopharyngeal cancer - a pilot study -
Scientific Title:Acronym Transoral robotic sugery for laryngopharyngeal cancer - a pilot study -
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 I

Assessment
Primary outcomes Positive surgical martin rate
Key secondary outcomes Completion rate of surgery, hospitalzation period, NG tube or PEG dependency rate

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 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 advanced cancer which needs systemic treatment
#History of radiation therapy for the primary 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 7

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
Email 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
Email murayama@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

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
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 京都大学医学部附属病院
東京医科大学附属病院
鳥取大学医学部附属病院

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 No longer recruiting
Date of protocol fixation
2013 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 12 Month 01 Day
Last follow-up date
2015 Year 03 Month 31 Day
Date of closure to data entry
2015 Year 03 Month 31 Day
Date trial data considered complete
2015 Year 03 Month 31 Day
Date analysis concluded
2016 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 10 Month 28 Day
Last modified on
2016 Year 02 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014195

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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