UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021904 |
|---|---|
| Receipt number | R000025251 |
| Scientific Title | Prospective observational results of pulmonary resection for over 75 years-old patients with non-small cell lung cancer - Multi-institutional study in Japan - |
| Date of disclosure of the study information | 2016/04/17 |
| Last modified on | 2018/04/10 11:28:33 |
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Basic information
Public title
Prospective observational results of pulmonary resection for over 75 years-old patients with non-small cell lung cancer - Multi-institutional study in Japan -
Acronym
Prospective observational study of pulmonary resection for elderly patients with lung cancer
Scientific Title
Prospective observational results of pulmonary resection for over 75 years-old patients with non-small cell lung cancer - Multi-institutional study in Japan -
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Tokujiro Yano |
Organization
National Hospital Organization Beppu Medical Center
Division name
General Thoracic Surgery
Zip code
Address
1473 Uchikamado, Beppu
TEL
0977-67-11111
tokujiro@hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tokujiro Yano |
Organization
National Hospital Organization Beppu Medical Center
Division name
General Thoracic Surgery
Zip code
Address
1473 Uchikamado, Beppu
TEL
0977-67-11111
Homepage URL
tokujiro@hosp.go.jp
Sponsor or person
Institute
Dept. General Thoracic Surgery,
National Hospital Organization Beppu Medical Center
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
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)
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
Completed
Date of protocol fixation
| 2014 | Year | 01 | Month | 14 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025251
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
