臨床研究等提出・公開システム

Japanese

Date of registration	July. 14, 2024
Last modified on	July. 14, 2024
Trial ID	jRCT1070240032

Scientific Title	Study of selective neck dissection navigated by sentinel node biopsy for T3-4aN0 advanced oral cancers (multiinstitutional randomized control study)
Public Title	Study of selective neck dissection navigated by sentinel node biopsy

Contact for Scientific Queries	Name	Hirakawa Hitoshi
	Affiliation	University of the Ryukyus
	Address	Okinawa Nishihara 207
	Telephone	+81-98-895-1183
	E-mail	hanntagawa@hotmail.com
Contact for Public Queries	Name	Agena Shinya
	Affiliation	University of the Ryukyus
	Address	Okinawa Nishihara 207
	Telephone	+81-98-895-1183
	E-mail	harugen3@yahoo.co.jp

Recruitment status	Pending

Anticipated date of first enrollment		July. 14, 2024
Target sample size		187
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1) Patients with T3-4 oral squamous cell carcinoma without lymph node metastasis 2) Patients with no previous treatment for head and neck cancer 3) Patients who are at least 18 years old at the time of consent 4) Patients with written consent from the patient.
	Exclusion Criteria	1) Cases with PORT indication (extracapsular invasion, multiple cervical metastases) 2) Cases previously treated with cervical radiation 3) Pregnant or suspected pregnant 4) Cases with serious complications that do not tolerate radical surgery in the judgment of the attending physician 5) Cases deemed inappropriate for this study by the treating physician for other reasons
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		T3-4N0,Oral Cancer
Intervention(s)		Control group: Selective Neck Dissection Experimental group: SN-assisted selective neck dissection
Health Condition(s) Keyword		oral neoplasm
Intervention(s) Keyword		Neck dissection
Health Condition(s) Code		D009062
Intervention(s) Code		Q000601
Primary Outcome(s)		3-year neck recurrence-free survival rate
Secondary Outcome(s)		3-year crude survival rate, 3-year recurrence-free survival rate, postoperative dysfunction of neck dissection, SN false negative rate

Primary Sponsor	PDR PHARMA

Name of Certified Review Board	Clinical Research Ethics Review Committee, University of the Ryukyus
Address	Nishihara city, Nakagamigun, Senbaru 1, Okinawa
Telephone	+81-98-895-1542
E-Mail	krinken@acs.u-ryukyu.ac.jp
Approval Status	Approval
Date of approval	Mar. 07, 2024

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none