UMIN-CTR Clinical Trial

Public title

Prospective Observational Study of Elective Neck Dissection for clinical N0 Tongue Cancer

Acronym

END-TC

Scientific Title

Prospective Observational Study of Elective Neck Dissection for clinical N0 Tongue Cancer

Scientific Title:Acronym

END-TC

Region

Japan

Condition

clinical N0 squamous cell carcinoma of tongue

Classification by specialty

Oral surgery

Dental medicine

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Verify the efficacy of elective neck dissection for cN0 tongue cancer.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

3 year-overall survival rate

Key secondary outcomes

3 year-disease-specific survival rate, 3 year-relapse-free survival rate, quality of life evaluation

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) squamous cell carcinoma of the tongue2) Clinical and diagnostic imaging is cN0 in UICC 7th and 8th editions
3) No apparent distant metastasis
4) The age at the time of consent acquisition is 20 years old or over
5) PS (ECOG) is 0 or 1
6) Main organ function is maintained and curative surgery is possible
7) Document consent has been obtained regarding participation of this research by radical curative surgery

Key exclusion criteria

1) Cases with history of treatment with malignant tumors in head and neck area
2) Cases with active multiple cancer with a disease-free period of less than 5 years back from the date of registration (healed skin basal cell carcinoma and cervical carcinoma, or gastric cancer cured by endoscopic mucosal resection, esophageal carcinoma, Colorectal cancer cases can be registered)
3) Case in which psychosis or psychiatric symptoms are complicated and it is judged that it is difficult to participate in this study
4) Other cases that the physician judged inappropriate as the subject of this study

Target sample size

800

Name of lead principal investigator

1st name	Masahiro
Middle name
Last name	Umeda

Organization

Nagasaki University

Division name

Department of Clinical Oral Oncology

Zip code

852-8588

Address

1-7-1 Sakamoto, Nagasaki

TEL

095-819-7698

Email

mumeda@nagasaki-u.ac.jp

Name of contact person

1st name	Souichi
Middle name
Last name	Yanamoto

Organization

Nagasaki University

Division name

Dentistry for Medically Compromised Patient

Zip code

852-8588

Address

1-7-1 Sakamoto, Nagasaki

TEL

095-819-7698

Homepage URL

Email

syana@nagasaki-u.ac.jp

Institute

Nagasaki University

Institute

Department

Personal name

Organization

Nagasaki University

Organization

Division

Category of Funding Organization

Government offices of other countries

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Nagasaki University Hospital Clinical Research Ethics Committee

Address

1-7-1 Sakamoto, Nagasaki

Tel

095-819-7229

Email

gaibushikin@ml.nagasaki-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

06

Month

22

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

Open public recruiting

Date of protocol fixation

2017

Year

06

Month

22

Day

Date of IRB

2017

Year

06

Month

20

Day

Anticipated trial start date

2017

Year

11

Month

01

Day

Last follow-up date

2026

Year

10

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

After enrolling a patient with curative cN0 tongue squamous cell carcinoma capable of curative surgery, radical surgery was performed, patients were divided between patients who had undergone prophylactic cervical dissection and patients who did not undergo radical surgery, and prospective observational studies.
The observation items are as follows.
1) Information on registration
Patient information, Disease information, ECOG systemic symptom scale, radical surgery day, Life history, Allergy, History of history, Evaluation of primary lesion: site, depth of tumor (Depth of Invasion; DOI mm) , US, others), Preoperative treatment, QOL evaluation: FACT-H&N ver. 4 Japanese version and DASH Japanese version, Perioperative period Oral function management
2) Information on treatment
surgical contents, postoperative pathological examination, postoperative adjuvant therapy
3) Observation information
Palpation or US is essential. Combine head and neck contrast CT or MRI once every 3 months. Chest radiograph or chest or abdominal CT are performed once every 6 months after treatment is completed.
Observation date, Observation method, Outcome, recurrence, Secondary cancer, QOL evaluation, Late cervical lymph node metastasis appearance, postoperative adjuvant chemotherapy when the treatment of cervical lymphadenectomy is performed.

Registered date

2017

Year

06

Month

22

Day

Last modified on

2020

Year

08

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031938