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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000013233
Receipt No. R000015443
Scientific Title A prospective observational study of the surgery for lung cancer in patients with low pulmonary function
Date of disclosure of the study information 2014/02/24
Last modified on 2018/03/06

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Basic information
Public title A prospective observational study of the surgery for lung cancer in patients with low pulmonary function
Acronym A prospective observational study of the surgery for lung cancer in patients with low pulmonary function
Scientific Title A prospective observational study of the surgery for lung cancer in patients with low pulmonary function
Scientific Title:Acronym A prospective observational study of the surgery for lung cancer in patients with low pulmonary function
Region
Japan

Condition
Condition Primary lung cancer, Chronic Obstructive Lung Disease (COPD)
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We will investigate the surgery of lung cancer in patients with chronic obstructive pulmonary disease (COPD). And, we will perform this study with "Exploratory randomized trial of evaluation for Tiotropium in lung cancer surgery (UMIN000012217)" at the same time.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1- year overall survival
Key secondary outcomes 1)Rate of cardiopulmonary complications after surgery
2)Detail of cardiopulmonary complications after surgery
3)Rate of post operative complications excluding cardiopulmonary complications
4)Improvement of pulmonary function before and after using of drugs for COPD
5)Evaluation of the postoperative complications using the Clavien-Dindo classification
6)3-years overall survival
7)Rate of adverse events
8)Evaluation of postoperative compliance

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Clinically suspected primary lung cancer.
2) Postbronchodilator FEV1/FVC (forced expiratory volume in 1s/forced vital capacity) < 0.70 assessed by spirometry.
3) Resectable cancer lesion by surgery less than single lobectomy.
4) Without previously treatment for bronchial asthma.
5) No past pulmonary resection excluding wedge resection.
6) Patients stopping smoking at the time of giving the consent to this study.
7) Adequate organ function tolerable for the general anesthesia.
8) Age of 20 years or older.
9) ECOG (Eastern Cooperative Oncology Group) performance status (PS) 0, 1, 2.
10) Written informed consent to participate.
Key exclusion criteria 1) Median sternotomy.
2) Combined resection of the chest wall excluding parietal pleura excision.
3) History of active infection.
4) Active double cancer within 5 years of disease-free interval, except for curable lesions like
carcinoma in situ and mucosal cancer.
5) Patients with glaucoma.



6) Patients with dysuria.
7) History of hypersensitivity to atropine or drugs similar to atropine.
8) Patients with interstitial pneumonia or pulmonary fibrosis.
9) Patients with arrhythmia requiring antiarrhythmic continuously.
10) Patients with thyropathy.
11) Patients with renal dysfunction needs blood purification therapy.
12) Patients with psychiatric disease.
13) Patients requiring systemic steroids medication.
14) Patients with uncontrolled diabetes mellitus.
15) Patients with uncontrolled hypertension.
16) Current or previous within the last 6 months history of severe heart diseases, cerebrovascular
disease.
17) The pregnant and lactating female , female who has possibility of the pregnancy.
18) Patients who were judged inappropriate to entry this study by physician.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiro Tsuboi
Organization National Cancer Center Hospital East
Division name Thoracic Surgery
Zip code
Address 6-5-1 kashiwanoha, Kashiwa City, 277-8577, Japan
TEL 04-7133-1111
Email mtsuboi@za2.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Teppei Nishii
Organization Yokohama City University Medical Center
Division name Thoracic Surgery
Zip code
Address 1-1-2 Nakao,Asahi-ku,YokohamaCity,241-0815,Japan
TEL 045-391-5761
Homepage URL
Email t-nishii@kcch.jp

Sponsor
Institute Yokohama City University Medical Center
Institute
Department

Funding Source
Organization None
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
Email

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 横浜市立大学附属市民総合医療センター(神奈川県)
神奈川県立がんセンター(神奈川県)
順天堂大学医学部附属順天堂医院(東京都)
広島大学病院(広島県)
国立がん研究センター東病院(千葉県)
千葉県がんセンター(千葉県)
近畿大学医学部附属病院(大阪府)
東京医科大学病院(東京都)
聖マリアンナ医科大学病院(神奈川県)
産業医科大学病院(福岡県)
山口大学医学部附属病院(山口県)
新潟県立がんセンター新潟病院(新潟県)
倉敷中央病院(岡山県)

Other administrative information
Date of disclosure of the study information
2014 Year 02 Month 24 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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 No longer recruiting
Date of protocol fixation
2013 Year 12 Month 15 Day
Date of IRB
Anticipated trial start date
2014 Year 02 Month 24 Day
Last follow-up date
2018 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We will investigate the surgery of lung cancer in patients with chronic obstructive pulmonary disease (COPD). And, we will perform this study with "Exploratory randomized trial of evaluation for Tiotropium in lung cancer surgery (UMIN000012217)" at the same time.

Management information
Registered date
2014 Year 02 Month 24 Day
Last modified on
2018 Year 03 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015443

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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