UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006510 |
|---|---|
| Receipt number | 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 09:27:54 |
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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
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
hasegawa@aichi-cc.jp
Sponsor or person
Institute
Aichi Cancer Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007724
