UMIN-CTR Clinical Trial

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

Squamous cell carcinoma of oral cavity

Classification by specialty

Oral surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Osaka University Graduate School of Dentistry
Oral Cancer Treatment Group

Institute

Department

Personal name

Organization

public money

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

大阪大学歯学部附属病院

Date of disclosure of the study information

2014

Year

07

Month

25

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2014

Year

07

Month

24

Day

Last modified on

2018

Year

07

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007395