UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety of thoracoscopic surgery for locally advanced lung cancer
Title of the study (Brief title)	Safety of thoracoscopic surgery for locally advanced lung cancer
Region	Japan

Condition
Condition	lung cancer
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the safety of thoracoscopic surgery for locally advanced lung cancer
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Surgery completion rate
Key secondary outcomes	Operative time, blood loss, hospital stay, (intra- and postoperative) morbidity and operative mortality

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	video-assisted thoracic surgery
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Clinical stage 2 - 4 lung cancer Age of 20 to 85 years old at the informed consent Eastern Cooperative Oncology Group performance status of 0 to 1 Written informed concent
Key exclusion criteria	lung abscess progressive disease with unexpected growth of tumor multiple organ cancer severe or complicated medical condition not tolerable of general anesthesia infection body temperature over 38 degrees Celsius pregnancy psychiatric disorder unstable angina and myocardial infarction refused blood transfusion smoking not allowing participation into this protocol
Target sample size	30

Research contact person
Name of lead principal investigator	Ryoichi Nakanishi
Organization	Nagoya City University
Division name	Department of Oncology, Immunology and Surgery
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya city
TEL	052-853-8231
Email	Ryoichi@med.nagoya-cu.ac.jp

Public contact
Name of contact person	Satoru Moriyama
Organization	Nagoya City University
Division name	Department of Oncology, Immunology and Surgery
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya city
TEL	052-853-8231
Homepage URL
Email	mohihige@med.nagoya-cu.ac.jp

Sponsor
Institute	Nagoya City University
Institute
Department

Funding Source
Organization	Nagoya City University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2015 Year 10 Month 22 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 09 Month 07 Day
Anticipated trial start date	2015 Year 10 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 10 Month 21 Day
Last modified on	2017 Year 09 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022490