UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012217 |
|---|---|
| Receipt number | R000014286 |
| Scientific Title | Exploratory randomized trial of evaluation for Tiotropium in lung cancer surgery |
| Date of disclosure of the study information | 2013/11/05 |
| Last modified on | 2022/03/16 12:25:28 |
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Basic information
Public title
Exploratory randomized trial of evaluation for Tiotropium in lung cancer surgery
Acronym
Exploratory randomized trial of evaluation for Tiotropium in lung cancer surgery
Scientific Title
Exploratory randomized trial of evaluation for Tiotropium in lung cancer surgery
Scientific Title:Acronym
Exploratory randomized trial of evaluation for Tiotropium in lung cancer surgery
Region
| Japan |
Condition
Condition
Primary lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We will investigate the effect of Tiotropium on surgery for primary lung cancer exploratory in patients with Chronic Obstructive Lung Disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Rate of cardiopulmonary complications within 1 year after surgery
Key secondary outcomes
1)Improvement of pulmonary function before and after inhalation of Tiotropium
2)Rate of post operative complications excluding cardiopulmonary complications
3)3-years overall survival
4)Rate of adverse events
5)Evaluation of postoperative compliance
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Inhalation of Tiotropium, 5 microgram once daily, starting from 2 weeks before the surgery.
Interventions/Control_2
No inhalation of Tiotropium.
Other short acting anticholinergics or beta2-agonists are permissible.
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) Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria I - II (FEV1 => 50% of predicted value).
4) Modified Medical Research Council (MRC) score =< 1.
5) Resectable cancer lesion by surgery less than single lobectomy.
6) Without previously treatment for chronic obstructive pulmonary disease (COPD), bronchial
asthma.
7) No past pulmonary resection excluding wedge resection.
8) Patients stopping smoking at the time of giving the consent to this study.
9) Adequate organ function tolerable for the general anesthesia.
10) Capable of inhalation.
11) Age of 20 years or older.
12) ECOG (Eastern Cooperative Oncology Group) performance status (PS) 0-1.
13) 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
280
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Tsuboi |
Organization
National Cancer Center Hospital East
Division name
Thoracic Surgery
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa City, 277-8577, Japan
TEL
04-7133-1111
mtsuboi@za2.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Teppei |
| Middle name | |
| Last name | Nishii |
Organization
Yokohama City University Medical Center
Division name
Respiratory Disease Center
Zip code
232-0024
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
Homepage URL
nteppei@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
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
Yokohama City University Ethics Committee
Address
3-9 Fukuura,Kanazawa-ku,Yokohama 236-0004 Japan
Tel
045-370-7629
nextjim1@yokohama-cu.ac.jp
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）
山形県立中央病院（山形県）
仙台厚生病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 11 | Month | 05 | 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
43
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 | 03 | Month | 02 | Day |
Date of IRB
| 2013 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2013 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 11 | Month | 05 | Day |
Last modified on
| 2022 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014286
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