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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002004
Receipt No. R000002441
Scientific Title Standardization of neck dissection procedures for hypopharyngeal and supraglottic carcinomas
Date of disclosure of the study information 2009/05/28
Last modified on 2013/11/25

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Basic information
Public title Standardization of neck dissection procedures for hypopharyngeal and supraglottic carcinomas
Acronym Standardization of neck dissection (hypopharyngeal & supraglottic ca.)
Scientific Title Standardization of neck dissection procedures for hypopharyngeal and supraglottic carcinomas
Scientific Title:Acronym Standardization of neck dissection (hypopharyngeal & supraglottic ca.)
Region
Japan

Condition
Condition hypopharyngeal carcinoma, supraglottic carcinoma
Classification by specialty
Surgery in general Oto-rhino-laryngology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To standardize neck dissection procedures so that patients with hypopharyngeal or supraglottic carcinoma treated in 17 participating hospitals undergo the same neck dissection procedure regarding the extent of resection of neck lymph nodes and non-lymphatic structures if the N-stage and side of operation (ipsilateral/contralateral) are the same.
Basic objectives2 Others
Basic objectives -Others To confirm the safety of "Recommendations for the extent of neck lymph node resection" and "Recommendations for surgical maneuvers for 4 key details of neck dissection".
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes 2-year neck control rate
Key secondary outcomes 1. Percentage of patients in whom the surgeon accepted "Recommendations for the extent of neck lymph node resection"
2. Percentage of patients where the surgeon accepted "Recommendations for surgical maneuvers for 4 key details of neck dissection"
3. 2-year overall survival rate, 2-year cause-specific survival rate

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 Treatment
Type of intervention
Maneuver
Interventions/Control_1 Neck dissection.
This protocol proposes "Recommendations for the extent of neck lymph node resection" for each N-stage and side of operation (ipsilateral or contralateral) and "Recommendations for the surgical maneuvers" for 4 key details of neck dissection.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients who have submitted written informed consent
2) Patients with squamous cell carcinoma of the hypopharynx or supraglottis
3) Previously untreated patients who undergo neck dissection during the first treatment
Key exclusion criteria 1) Patients with distant metastasis
2) Patients who underwent neck dissection in the past
3) Patients with a simultaneous secondary carcinoma which requires neck dissection
4) Patients with recurrent cancer
Target sample size 198

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahisa Saikawa
Organization National Cancer Center Hospital East
Division name Division of Head and Neck Surgery
Zip code
Address 6-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577, JAPAN
TEL 04-7133-1111
Email mhsaikaw@dd.iij4u.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahisa Saikawa
Organization National Cancer Center Hospital East
Division name Division of Head and Neck Surgery
Zip code
Address 6-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577, JAPAN
TEL 04-7133-1111
Homepage URL
Email mhsaikaw@dd.iij4u.or.jp

Sponsor
Institute The Japan Neck Dissection Study Group (JNDSG)
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare, JAPAN
Organization
Division
Category of Funding Organization
Nationality of Funding Organization JAPAN

Other related organizations
Co-sponsor none
Name of secondary funder(s) none

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 1. 独立行政法人国立がん研究センター東病院(千葉県)
2. 独立行政法人国立がん研究センター中央病院(東京都)
3. 宮城県立がんセンター(宮城県)
4. 埼玉県立がんセンター(埼玉県)
5. 埼玉医科大学国際医療センター(埼玉県)
6. 東京医科歯科大学医学部附属病院(東京都)
7. 東京大学医学部附属病院(東京都)
8. 慶応義塾大学病院(東京都)
9. 癌研有明病院(東京都)
10. 北里大学病院(神奈川県)
11. 神奈川県立がんセンター(神奈川県)
12. 名古屋大学医学部附属病院(愛知県)
13. 愛知県がんセンター中央病院(愛知県)
14. 大阪府立成人病センター(大阪府)
15. 神戸大学医学部附属病院(兵庫県)
16. 国立病院機構四国がんセンター(愛媛県)
17. 久留米大学病院(福岡県)

Other administrative information
Date of disclosure of the study information
2009 Year 05 Month 28 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 Completed
Date of protocol fixation
2009 Year 05 Month 19 Day
Date of IRB
Anticipated trial start date
2009 Year 06 Month 01 Day
Last follow-up date
2013 Year 12 Month 01 Day
Date of closure to data entry
2014 Year 01 Month 31 Day
Date trial data considered complete
2014 Year 02 Month 28 Day
Date analysis concluded
2014 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 05 Month 25 Day
Last modified on
2013 Year 11 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002441

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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