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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003213
Receipt No. R000003896
Scientific Title Standardization of the extent of resection in nonradical neck dissections
Date of disclosure of the study information 2010/02/23
Last modified on 2010/02/19

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Basic information
Public title Standardization of the extent of resection in nonradical neck dissections
Acronym Standardization of neck dissection
Scientific Title Standardization of the extent of resection in nonradical neck dissections
Scientific Title:Acronym Standardization of neck dissection
Region
Japan

Condition
Condition Head and neck cancer
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 head and neck cancer patients treated in 22 participating hospitals will undergo the same neck dissection procedure regarding the extent of resection of the neck lymph nodes and non-lymphatic structures if the primary site and stage are the same.
Basic objectives2 Others
Basic objectives -Others To explore the feasibility and effects of standardization of neck dissection procedures.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes 2-year neck control rate
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 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, in which a surgeon of another hospital observes the procedure directly and records its details according to a specialized form.
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 head and neck cancer
3) Previously untreated patients who undergo neck dissection during the first treatment
Key exclusion criteria 1) Patients with recurrent cancer
2) Patients with cancer of unknown primary site
3) Patients considered as inappropriate by their doctors
Target sample size 235

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

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@east.ncc.go.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. 国立がんセンター東病院(千葉県) National Cancer Center Hospital East, Chiba
2. 国立がんセンター中央病院(東京都) National Cancer Center Hospital, Tokyo
3. 宮城県立がんセンター(宮城県) Miyagi Cancer Center, Miyagi
4. 群馬県立がんセンター(群馬県) Gunma Cancer Center, Gunma
5. 埼玉県立がんセンター(埼玉県) Saitama Cancer Center, Saitama
6. 埼玉医科大学国際医療センター(埼玉県) Saitama Medical School, Saitama
7. 千葉県がんセンター(千葉県) Chiba Cancer Center Hospital, Chiba
8. 東京医科歯科大学医学部附属病院(東京都) Tokyo Medical and Dental University, Tokyo
9. 東京大学医学部附属病院(東京都) Graduate School of Medicine, University of Tokyo, Tokyo
10. 癌研有明病院(東京都) Cancer Institute Hospital, Tokyo
11. 国立病院機構東京医療センター(東京都) National Hospital Organization Tokyo Medical Center, Tokyo
12. 杏林大学医学部附属病院(東京都) Kyorin University School of Medicine, Tokyo
13. 神奈川県立がんセンター(神奈川県) Kanagawa Cancer Center, Kanagawa
14. 静岡県立静岡がんセンター(静岡県) Shizuoka Cancer Center, Shizuoka
15. 愛知県がんセンター中央病院(愛知県) Aichi Cancer Center Hospital, Aichi
16. 国立病院機構京都医療センター(京都府) National Hospital Organization Kyoto Medical Center, Kyoto
16. 大阪府立成人病センター(大阪府) Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka
18. 神戸大学医学部附属病院(兵庫県) Graduate School of Medicine, Kobe University, Hyogo
19. 国立病院機構四国がんセンター(愛媛県) National Hospital Organizationa Shikoku Cancer Center, Ehime
20. 高知大学医学部附属病院(高知県) Kochi Medical School, Kochi
21. 国立病院機構九州がんセンター(福岡県) National Kyushu Cancer Center, Fukuoka
22. 久留米大学病院(福岡県) Kurume University School of Medicine, Fukuoka

Other administrative information
Date of disclosure of the study information
2010 Year 02 Month 23 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://springerlink.metapress.com/content/x5650u23026587v6/?p=3e53cc78c0544ddfb801780c82473fa4&pi=3
Number of participants that the trial has enrolled
Results
1. A total of 235 patients were enrolled between Feb. 18, 2004 and Nov. 22, 2006.
2. The follow-up of this study was completed on July 27, 2009. The percentage of patients with a follow-up less than 2 years was 2.3%.
3. Of the 79 questions of the observation form, difference among participating hospitals was confirmed in 13 details and strongly suspected in 7 details.
4. To standardize these 20 details, JNDSG established a manual, "Standard Surgical Maneuvers for Each Detail of Neck Dissection," based on the discussion about the optimal procedures concerning each detail.
5. As the study proceeded from the first to the second stage, the intensity of difference among the hospitals decreased in 11 details and increased in 6 details. Because there were more details showing decreased intensity, this study was concluded to have contributed to some extent to the standardization of nonradical neck dissections in Japan.
6. Although standardization of a surgical procedure in a multi-institutional setting is a very rare undertaking, this study achieved noteworthy success.
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
2003 Year 11 Month 27 Day
Date of IRB
Anticipated trial start date
2004 Year 02 Month 01 Day
Last follow-up date
2009 Year 07 Month 01 Day
Date of closure to data entry
2009 Year 07 Month 01 Day
Date trial data considered complete
2009 Year 08 Month 01 Day
Date analysis concluded
2009 Year 09 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 02 Month 19 Day
Last modified on
2010 Year 02 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003896

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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