UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility study of sentinel node navigation surgery for head and neck cancer.
Title of the study (Brief title)	Sentinel node navigation surgery for head and neck cancer.
Region	Japan

Condition
Condition	Head and neck cancer, Oral cancer, Laryngopharyngeal cancer.
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Feasibility, effectiveness, surgical invasiveness is evaluated for head and neck cancer patients who undergo sentinel node naviation surgery.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Primary endopoint is 5 year disease specific survival
Key secondary outcomes	5 year over all survival, local control rate, cervical lymph node recurrence rate, QOL of shoulder function

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	One day before surgery, 99mTc phytate is injected around the tumor. During surgery, sentinel lymph node is detected and frozen section analysis is performed. In case of metastasis positive, neck dissection is performed and in nagative case, neck dissection is omitted.
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	80 years-old >=
Gender	Male
Key inclusion criteria	T1-T2,N0 Oral, laryngeal, pharyngeal cancer
Key exclusion criteria	Recurrent case after initial treatment.
Target sample size	20

Research contact person
Name of lead principal investigator	Masayuki Tomifuji
Organization	National Defense Medical College
Division name	Otolaryngology
Address	3-2 Namiki, Tokorozawa, Saitama, Japan
TEL	04-2995-1211
Email	tomifuji@ndmc.ac.jp

Public contact
Name of contact person	Masayuki Tomifuji
Organization	National Defense Medical College
Division name	Otolaryngology
Address	3-2 Namiki, Tokorozawa, Saitama, Japan
TEL	04-2995-1211
Homepage URL
Email	tomifuji@ndmc.ac.jp

Sponsor
Institute	National Defense Medical College
Institute
Department

Funding Source
Organization	National Defense Medical College
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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	防衛医科大学校（埼玉県）

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 01 Month 18 Day
Anticipated trial start date	2017 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2017 Year 01 Month 21 Day
Last modified on	2017 Year 01 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029661