UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of safety and efficacy of transoral robotic surgery for laryngo-pharyngeal cancer
Acronym	Evaluation of safety and efficacy of transoral robotic surgery for laryngo-pharyngeal cancer
Scientific Title	Phase II trial of transoral robotic surgery for laryngo-pharyngeal cancer
Scientific Title:Acronym	Phase II trial of transoral robotic surgery for laryngo-pharyngeal cancer
Region	Japan

Condition
Condition	Laryngo-pharyngeal cancer
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate safety and efficacy of transoral robotic surgery for laryngo-pharyngeal cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Positive rate of surgical margin
Key secondary outcomes	Postoperative swallowing function

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	Not applicable
Gender	Male and Female
Key inclusion criteria	(1) Oropharyngeal, Hypopharyngeal or supraglottic cancer confirmed by pathological diagnosis (2) Tis-T2 or superficial T3 diagnosed by endoscopy or imaging test (CT, MRI or PET/CT) (3) Tumor invasion within pharyngeal constrictor (4) N0-N2b in p16-negative oropharyngeal, hypopharyngeal or supraglottic cancer (5) N0-1 in p16-positive oropharyngeal cancer (6) ECOG-PS 0-1 (7) Blood test results meeting the following requirements 1) Leukocyte count < 2,000/mm3 2) Platelate count < 100,000/mm3 3) AST= or <100 IU/L, ALT= or <100 IU/L 4) Total bilirubin= or <2.0 mg/dL (8) Age= or >20 (9) Providing written informed consent
Key exclusion criteria	(1) Poor exposure of surgical field due to trismus or difficulty of neck extension (2) Extranodal extention of lymph node metastasis (3) bilateral cervical lymph node metastases (4) Distant metastasis (5) Difficulty of discontinuation of anticoagulant or antiplatelet drug (6) Pregnancy (7) Unsuitable for inclusion at the discretion of the researchers
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Taku Middle name Last name Yamashita
Organization	Kitasato University
Division name	School of Medicine
Zip code	252-0374
Address	1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL	042-778-8111
Email	tyamahns@kitasato-u.ac.jp

Public contact
Name of contact person	1st name Shunsuke Middle name Last name Miyamoto
Organization	Kitasato University
Division name	School of Medicine
Zip code	252-0374
Address	1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL	042-778-8111
Homepage URL
Email	s-miya@kitasato-u.ac.jp

Sponsor
Institute	Kitasato University, School of Medicine
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The Kitasato University Medical Ethics Organization
Address	1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa
Tel	042-778-8111
Email	rinrib@med.kitasato-u.ac.jp

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	2019 Year 08 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	Preinitiation
Date of protocol fixation	2019 Year 05 Month 03 Day
Date of IRB
Anticipated trial start date	2019 Year 08 Month 01 Day
Last follow-up date	2024 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	2019 Year 05 Month 03 Day
Last modified on	2019 Year 05 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041746

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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