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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006510
Receipt No. R000007724
Scientific Title A randomized controlled trial of neck dissections based on sentinel lymph node navigation versus standard selective neck dissections in N0 oral cancers
Date of disclosure of the study information 2011/10/17
Last modified on 2020/10/20

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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

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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