UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003213
Receipt number 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 16:51:05

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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 or person

Institute

The Japan Neck Dissection Study Group (JNDSG)

Institute

Department

Personal name



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

Value
https://center6.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