UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014633
Receipt number 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 09:09:15

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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

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

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 or person

Institute

Osaka University Graduate School of Dentistry
Oral Cancer Treatment Group

Institute

Department

Personal name



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

Value
https://center6.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