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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017578
Receipt No. R000020369
Scientific Title Platinum concentration in sentinel lymph nodes after preoperative intra-arterial cisplatin chemotherapy targeting oral cancer
Date of disclosure of the study information 2015/05/15
Last modified on 2015/05/15

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Basic information
Public title Platinum concentration in sentinel lymph nodes after preoperative intra-arterial cisplatin chemotherapy targeting oral cancer
Acronym Platinum concentration in sentinel lymph nodes
Scientific Title Platinum concentration in sentinel lymph nodes after preoperative intra-arterial cisplatin chemotherapy targeting oral cancer
Scientific Title:Acronym Platinum concentration in sentinel lymph nodes
Region
Japan

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

Objectives
Narrative objectives1 To investigate intra-arterially injected cisplatin distribution to sentinel lymph nodes
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To compare platinum concentrations in sentinel lymph nodes and non-sentinel lymph nodes
Key secondary outcomes 1. Presence of metastasis to sentinel lymph nodes
2. histopathological effect to metastatic sentinel lymph nodes

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 angiography
intra-arterial infusion of cisplatin
sentinel lymph node biopsy
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 1. Histologically proven squamous cell carcinoma
2. Planned surgery for primary tumor
3. Written informed consent
Key exclusion criteria 1. Distant metastasis
2. Planned reconstruction by free flap transfer after primary tumor resection
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihiro Homma
Organization Hokkaido University Graduate School of Medicine
Division name Department of Otolaryngology-Head and Neck Surgery
Zip code
Address Kita 15, Nishi 7, Kita-ku, Sapporo 060-8638, Japan
TEL 011-706-5958
Email ak-homma@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akihiro Homma
Organization Hokkaido University Graduate School of Medicine
Division name Department of Otolaryngology-Head and Neck Surgery
Zip code
Address Kita 15, Nishi 7, Kita-ku, Sapporo 060-8638, Japan
TEL 011-706-5958
Homepage URL
Email ak-homma@med.hokudai.ac.jp

Sponsor
Institute Department of Otolaryngology-Head and Neck Surgery, Hokkaido University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Otolaryngology-Head and Neck Surgery, Hokkaido University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
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
2015 Year 05 Month 15 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
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
2009 Year 10 Month 30 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 30 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
2015 Year 05 Month 15 Day
Last modified on
2015 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020369

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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