UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002004 |
|---|---|
| Receipt number | 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 21:51:37 |
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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
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
mhsaikaw@dd.iij4u.or.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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002441
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| Registered date | File name |
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| Registered date | File name |
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