UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Muti instuitutional clinical study of transoral robotic surgery for laryngopharyngeal cancer
Title of the study (Brief title)	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,

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Ichiro Tateya
Organization	Kyoto University
Division name	Otolaryngology-Head & Neck Surgery
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	Toshinori Murayama
Organization	Kyoto University
Division name	Instititute for Advancement of Clinical and Translational Science
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 01 Month 07 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-bin/icdr_e/ctr_view.cgi?recptno=R000014203