UMIN-CTR Clinical Trial

Basic information
Public title	A randomized controlled trial of neck dissections based on sentinel lymph node navigation versus standard selective neck dissections in N0 oral cancers
Acronym	RCT of sentinel lymph node navigation surgery in oral cancers
Scientific Title	A randomized controlled trial of neck dissections based on sentinel lymph node navigation versus standard selective neck dissections in N0 oral cancers
Scientific Title:Acronym	RCT of sentinel lymph node navigation surgery in oral cancers
Region	Japan

Condition
Condition	Oral Cancer
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The objective of the study is to evaluate the non-Inferiority of survival and, the superiority of postoperative disability and complication of the neck in neck dissections based on sentinel lymph node navigation in N0 oral cancer patients, compared with standard selective neck dissections.
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	3 years overall survival
Key secondary outcomes	1)postoperative functional disability and complication of neck 2)3 years disease free survival 3)contralateral neck recurrence and false negative rate 4)accuracy of detecting of sentinel nodes and intraoperative diagnoses of their status

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Selective neck dissections based on sentinel lymph node navigation
Interventions/Control_2	Standard selective neck dissections
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Previously untreated and clinically negative neck oral squamous cell carcinoma patients (late T1 and T3) are the candidates for our study.
Key exclusion criteria	1)Previously treated patients 2)A history of radiation therapy for the neck 3)Pregnancy or lactating women, or women with suspected pregnancy 4)Patients judged by the investigator to be unfit to be enrolled into the study
Target sample size	256

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yasuhisa Hasegawa
Organization	Aichi Cancer Center
Division name	Department of Head and Neck Surgery
Zip code
Address	1-1 Kanokoden Chikusaku, Nagoya 464-8681, Japan
TEL	052-764-2944
Email	hasegawa@aichi-cc.jp

Public contact
Name of contact person	1st name Middle name Last name Yasuhisa Hasegawa
Organization	Aichi Cancer Center
Division name	Department of Head and Neck Surgery
Zip code
Address	1-1 Kanokoden Chikusaku, Nagoya 464-8681, Japan
TEL	052-762-6111
Homepage URL
Email	hasegawa@aichi-cc.jp

Sponsor
Institute	Aichi Cancer Center
Institute
Department

Funding Source
Organization	Health and Labor Sciences Research Grant for Clinical Cancer Research (H21-Gannorinshou-Ippan-016)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2011 Year 10 Month 17 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	275
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	Completed
Date of protocol fixation	2011 Year 07 Month 19 Day
Date of IRB	2011 Year 09 Month 02 Day
Anticipated trial start date	2011 Year 11 Month 26 Day
Last follow-up date	2019 Year 01 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	2011 Year 10 Month 10 Day
Last modified on	2020 Year 10 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007724