UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of selective neck dissections based on sentinel lymph node navigation in oral cancers
Title of the study (Brief title)	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 validity of selective neck dissections based on sentinel lymph node navigation in N0 oral cancer patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	We evaluate the false negative rate of selective neck dissections based on sentinel lymph node status.
Key secondary outcomes	We focus on the accuracy of detecting of sentinel nodes and intraoperative diagnoses of their status, the false negative rate in follow-up and impact on patient survival.

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	Maneuver
Interventions/Control_1	Selective neck dissections based on sentinel lymph node navigation
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	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 T2 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	56

Research contact person
Name of lead principal investigator	Yasuhisa Hasegawa
Organization	Aichi Cancer Center
Division name	Department of Head and Neck Surgery
Address	1-1 Kanokoden Chikusaku, Nagoya 464-8681
TEL	052-762-6111
Email	hasegawa@aichi-cc.jp

Public contact
Name of contact person	Yasuhisa Hasegawa
Organization	Aichi Cancer Center
Division name	Department of Head and Neck Surgery
Address	1-1 Kanokoden Chikusaku, Nagoya 464-8681
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
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2011 Year 02 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 08 Month 30 Day
Anticipated trial start date	2009 Year 12 Month 01 Day
Last follow-up date	2013 Year 12 Month 01 Day
Date of closure to data entry	2014 Year 06 Month 01 Day
Date trial data considered complete	2014 Year 06 Month 01 Day
Date analysis concluded	2014 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 01 Month 25 Day
Last modified on	2017 Year 01 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005894