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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014633
Receipt No. R000007395
Scientific Title The study on usefulness of selective neck dissection (level I-IV) for the oral squamous cell carcinoma patients with cervical metastases.
Date of disclosure of the study information 2014/07/25
Last modified on 2018/07/27

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Basic information
Public title The study on usefulness of selective neck dissection (level I-IV) for the oral squamous cell carcinoma patients with cervical metastases.
Acronym The study on usefulness of selective neck dissection (level I-IV) for the oral squamous cell carcinoma patients with cervical metastases.
Scientific Title The study on usefulness of selective neck dissection (level I-IV) for the oral squamous cell carcinoma patients with cervical metastases.
Scientific Title:Acronym The study on usefulness of selective neck dissection (level I-IV) for the oral squamous cell carcinoma patients with cervical metastases.
Region
Japan

Condition
Condition Squamous cell carcinoma of oral cavity
Classification by specialty
Oral surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effects of selective neck dissection (level I-IV) for oral SCC patients with cervical metastases on the regional control and avoidance of functional disorders.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Prognosis
1)regional recurrence
2)rate of regional control
3)survival rate
Functional disorders
1)function of spinal accessory nerve
2)uncomfortable symptom of neck (pain,limitation of movement , etc)
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 Surgical procedure
Selective neck dissection (level I-IV) is performed in accordance with standard functional neck dissection. Internal jugular vein, spinal accessory nerve and sternocleidomastoid muscle are preserved as possible.
We decide wheather or not level Ia and IIb are included into dissection according to next criteria;
1) Level Ia is included when the primary site is located lip, anterior portion of oral floor and oral tongue and lower gum between both canine.
2) Level IIb is included when there are metastases in level Ia.

The postoperative irradiation is considered according to the histological finding of surgical specimen as follows;
1) when extracapsular spreading is observed
2) when more than 3 metastatic lymph nodes are observed.
The extent of postoperative irradiation includes level I-V.
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) clinical N+ case (using CT, MRI, ECHO and PET)
(2) N stage: N1, N2a, N2b or N2c and no fixed lymph nodes
(3) No metastatic lymph nodes in level V
(4) Primary sites are lip, mobile tongue, oral floor, gingival and buccal mucosa (no infiltration into oropharyngeal).
(5) More than 18 year old
(6) No systemic problem
(7) PS 0-1 (ECOG)
(8)
Key exclusion criteria (1)Cases who do not meet the inclusion criteria
(2)Cases who judges improper for level I-IV dissection by surgeon during operation
Target sample size 30

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Mitsuhiro Nakazawa
Organization Osaka University Dental Hospital
Division name 2nd Department of Oral and Maxillofacial Surgery
Zip code
Address 1-8 Yamadaoka Suita Osaka
TEL 06-6879-2941
Email nakazawa@dent.osaka-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Mitsuhiro Nakazawa
Organization Osaka University Dental Hospital
Division name 2nd Department of Oral and Maxillofacial Surgery
Zip code
Address 1-8 Yamadaoka Suita Osaka
TEL 06-6879-2941
Homepage URL
Email nakazawa@dent.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Dentistry
Oral Cancer Treatment Group
Institute
Department

Funding Source
Organization public money
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 大阪大学歯学部附属病院

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 25 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
2011 Year 10 Month 21 Day
Date of IRB
Anticipated trial start date
2011 Year 12 Month 01 Day
Last follow-up date
2017 Year 12 Month 31 Day
Date of closure to data entry
2017 Year 12 Month 31 Day
Date trial data considered complete
2017 Year 12 Month 31 Day
Date analysis concluded
2018 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2014 Year 07 Month 24 Day
Last modified on
2018 Year 07 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007395

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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