臨床研究等提出・公開システム

Japanese

Date of registration	Jan. 17, 2019
Last modified on	June. 07, 2023
Trial ID	jRCT2011180004

Scientific Title	Landiolol Hydrochloride During Perioperative Period for completely resected NSCLC (Premium Land study)
Public Title	Prevention of metastasis by an ultra-short acting and the most selective beta1 blocker, Landiolol (Premium Land study)

Contact for Scientific Queries	Name	Hida Yasuhiro
	Affiliation	Fujita Health University
	Address	1-98 Dengakugakubo, Kutsukake-cho,Toyoake, Aichi
	Telephone	+81-562-93-2000
	E-mail	yhida@med.hokudai.ac.jp
Contact for Public Queries	Name	Horie Nao
	Affiliation	Hokkaido University Hospital
	Address	North 14 West 5,Kita-ku,Sapporo,Hokkaido, 060-8648 Japan
	Telephone	81-11-706-7735
	E-mail	pO_CcHUR001P-LAND@pop.med.hokudai.ac.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Jan. 04, 2019
Actual date of first enrollment		Jan. 23, 2019
Target sample size		400
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	prevention purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1.NSCLC is suspected. 2.Radiologically diagnosed invasive lung tumor (cT1a or more in UICC 8th edition) 3.Lobectomy, bi-lobectomy or pneumonectomy is intended 4.Mediastinal lymph node dissection ND2a-1 or more is intended 5.No history of cancer (carcinoma in situ is excluded) treatment within 5 years. 6.Performance Status(PS)0 or 1
	Exclusion Criteria	1.Malignant tumors within 5years 2.Mental disorders 3.Patients on beta agonists or antagonists 4.Preoperative treatments for NSCLC 5.Active infections 6.Contraindication to use ONO-1011
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		non-small cell lung cancer
Intervention(s)		Investigational new drug combination group: Complete resection surgery of non small cell lung carcinoma in combination with investigational new drug. The ONO-1101 is continuously administered intravenously. Surgery-alone group: Complete resection surgery for non small cell lung cancer.
Health Condition(s) Keyword		non-small cell lung cancer
Intervention(s) Keyword		Infusions, Intravenous
Health Condition(s) Code		D002289
Intervention(s) Code		D007262
Primary Outcome(s)		Relapse-free survival [Time Frame: 2 years] Over all survival [Time Frame: Through study completion, an average of 3 years]
Secondary Outcome(s)		1)Efficacy/ Evaluation of treatments after relapse [Time Frame: Up to 4 years and 5 months] 2)Safety/ Evaluation of adverse event, blood pressure, 12-lead electrocardiography, clinical laboratory test [Time Frame: Up to 7 days after surgery] Evaluation of incidence of perioperative complication [Time Frame: Up to 30 days after surgery]

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Ono Pharmaceutical Co., Ltd.
Secondary Sponsor	Not applicable

Name of Certified Review Board	Hokkaido University Hospital Institutional Review Board
Address	North 14 West 5,Kita-ku,Sapporo, 060-8648 Japan, Hokkaido
Telephone	81-11-706-7061
E-Mail	tiken@med.hokudai.ac.jp
Approval Status	Approval
Date of approval	Dec. 18, 2018

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
11	June. 07, 2023	(this page)	Changes
10	Nov. 22, 2022	Detail	Changes
9	Mar. 31, 2022	Detail	Changes
8	Aug. 23, 2021	Detail	Changes
7	July. 30, 2021	Detail	Changes
6	April. 20, 2021	Detail	Changes
5	Feb. 05, 2021	Detail	Changes
4	July. 03, 2020	Detail	Changes
3	Feb. 04, 2019	Detail	Changes
2	Jan. 23, 2019	Detail	Changes
1	Jan. 17, 2019	Detail

List of change history