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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000007038
Receipt No. R000008297
Scientific Title Evaluation of translymphatic chemotherapy targeting sentinel lymph nodes of patients with oral cancer using intra-arterial chemotherapy.
Date of disclosure of the study information 2012/01/10
Last modified on 2012/01/08

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Basic information
Public title Evaluation of translymphatic chemotherapy targeting sentinel lymph nodes of patients with oral cancer using intra-arterial chemotherapy.
Acronym oral cancer lymphatic chemotherapy
Scientific Title Evaluation of translymphatic chemotherapy targeting sentinel lymph nodes of patients with oral cancer using intra-arterial chemotherapy.
Scientific Title:Acronym oral cancer lymphatic chemotherapy
Region
Japan

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

Objectives
Narrative objectives1 Evaluate translymphatic chemotherapy targeting sentinel lymph nodes (SNL)of patients with oral cancer using intra-arterial chemotherapy by mesuring the CDDP consentration in SNL.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Evaluate CDDP concentration in SNL
Key secondary outcomes

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
Medicine Maneuver
Interventions/Control_1 lymphatic chemotherapy
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 Untreated oral squamous cell carcinoma (T2 orT3) patients with small neck metastasis (about 1cm).
Key exclusion criteria 1) distant metastasis
2) previously treated patients
3) A history of radiation therapy for the neck
4) pregnancy or lactating women or women with suspected pregnancy
5) Patients judged by the investigator to be unfit to be enrolled into the study
Target sample size 4

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junkichi Yokoyama
Organization Juntendo University school of medicine
Division name Department of Otolaryngology, head and neck surgery
Zip code
Address 2-1-1, Hongo, Bunkyou-ku, Tokyo
TEL 03-3813-3111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Shin Ito
Organization Juntendo University school of medicine
Division name Department of Otolaryngology, head and neck surgery
Zip code
Address
TEL
Homepage URL
Email shin709@juntendo.ac.jp

Sponsor
Institute Juntendo University school of medicinejyu
Institute
Department

Funding Source
Organization Health and Labor Science Reserch Grant for Clinical Cancer Research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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
2012 Year 01 Month 10 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 Enrolling by invitation
Date of protocol fixation
2011 Year 03 Month 22 Day
Date of IRB
Anticipated trial start date
2011 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 01 Month 08 Day
Last modified on
2012 Year 01 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008297

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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