UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The study on usefulness of selective neck dissection (level I-IV) for the oral squamous cell carcinoma patients with cervical metastases.
Title of the study (Brief title)	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
Name of lead principal investigator	Mitsuhiro Nakazawa
Organization	Osaka University Dental Hospital
Division name	2nd Department of Oral and Maxillofacial Surgery
Address	1-8 Yamadaoka Suita Osaka
TEL	06-6879-2941
Email	nakazawa@dent.osaka-u.ac.jp

Public contact
Name of contact person	Mitsuhiro Nakazawa
Organization	Osaka University Dental Hospital
Division name	2nd Department of Oral and Maxillofacial Surgery
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 10 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000007395