UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective observational results of pulmonary resection for over 75 years-old patients with non-small cell lung cancer - Multi-institutional study in Japan -
Title of the study (Brief title)	Prospective observational study of pulmonary resection for elderly patients with lung cancer
Region	Japan

Condition
Condition	Non-small cell lung cancer
Classification by specialty	Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	In an aging society, the lung cancer population is also aging. Since the comorbidities increase with age, both postoperative mortality and morbidity of pulmonary resection for elderly patients with non-small cell lung cancer (NSCLC) have been reported to be higher than those for non-elderly patients. However, results reported until now are retrospective and single institutional. We conducted a multi-institutional and prospectively observational study for > 75 years patients with completely resected NSCLC.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Operative morbidity
Key secondary outcomes	Operative mortality Risk factors of operative morbidity Postoperative change of KPS Postoperative survival

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	75 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Inclusion criteria for patients of the present study were as follows; 1)histologically confirmed as NSCLC 2)completely resected, including ipsilateral pulmonary metastasis (PM) and R0 (un), 3)75 or older than 75 years at the time of surgery.
Key exclusion criteria	Patient refusal
Target sample size	275

Research contact person
Name of lead principal investigator	Tokujiro Yano
Organization	National Hospital Organization Beppu Medical Center
Division name	General Thoracic Surgery
Address	1473 Uchikamado, Beppu
TEL	0977-67-11111
Email	tokujiro@hosp.go.jp

Public contact
Name of contact person	Tokujiro Yano
Organization	National Hospital Organization Beppu Medical Center
Division name	General Thoracic Surgery
Address	1473 Uchikamado, Beppu
TEL	0977-67-11111
Homepage URL
Email	tokujiro@hosp.go.jp

Sponsor
Institute	Dept. General Thoracic Surgery, National Hospital Organization Beppu Medical Center
Institute
Department

Funding Source
Organization	National Hospital Organization
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	旭川医療センター、帯広病院、北海道がんセンター、西新潟中央病院、水戸医療センター、渋川医療センター、高崎総合医療センター、東京医療センター、東京病院、横浜医療センター、長良医療センター、東広島医療センター、呉医療センター、四国がんセンター、高知病院、九州がんセンター、九州医療センター、嬉野医療センター、長崎医療センター、別府医療センター、大阪医療センター、埼玉病院

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 01 Month 14 Day
Anticipated trial start date	2014 Year 03 Month 01 Day
Last follow-up date	2017 Year 05 Month 31 Day
Date of closure to data entry	2017 Year 08 Month 31 Day
Date trial data considered complete	2017 Year 12 Month 31 Day
Date analysis concluded	2018 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	1.Yano T, et al. A prospective observational study of pulmonary resection for non-small cell lung cancer in patients older than 75 years. Semin Thorac Cardiovasc Surg 2017, 29:540-547 2. Yano T, et al. The influence of comorbidity on the postoperative survival in elderly (>75 years old) patients with lung cancer. Gen Thorac Cardiovasc Surg, 2018 (in press)
Other related information	From March 2014 through April 2015, 314 preoperative patients were tentatively registered. Of those preoperatively registered patients, 264 were postoperatively identified to meet the inclusion criteria for this study. The reason for exclusion was no diagnosis of non-small cell lung cancer in 21 patients, incomplete resection in 19 patients, no performance of surgery in 6 and other reason in one.

Management information
Registered date	2016 Year 04 Month 14 Day
Last modified on	2018 Year 04 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025251