UMIN-CTR Clinical Trial

Basic information
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
Condition	clinical N0 squamous cell carcinoma of tongue
Classification by specialty	Oral surgery Dental medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
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

Assessment
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

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute	Nagasaki University
Institute
Department

Funding Source
Organization	Nagasaki University
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization

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

IRB Contact (For public release)
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
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 06 Month 22 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	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

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.

Management information
Registered date	2017 Year 06 Month 22 Day
Last modified on	2020 Year 08 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031938