UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012139
Receipt number 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 01:00:18

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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 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


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

Value
https://center6.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