UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014361 |
|---|---|
| Receipt number | R000016701 |
| Scientific Title | Exploratory randomized trial for evaluation of Salmeterol in lung cancer surgery |
| Date of disclosure of the study information | 2014/06/25 |
| Last modified on | 2020/12/28 10:52:44 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Exploratory randomized trial for evaluation of Salmeterol in lung cancer surgery
Acronym
Exploratory randomized trial for evaluation of Salmeterol in lung cancer surgery
Scientific Title
Exploratory randomized trial for evaluation of Salmeterol in lung cancer surgery
Scientific Title:Acronym
Exploratory randomized trial for evaluation of Salmeterol 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 Salmeterol on surgery for primary lung cancer in COPD patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Improvement of pulmonary function associated with inhalation of Salmeterol
Key secondary outcomes
1) Rate of postoperative complications
2) Self-assessment of respiratory insufficiency
3) 1-year 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
NO
Institution consideration
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Inhalation of Salmeterol, 50 microgram twice daily, starting from 10 days before the surgery.
Interventions/Control_2
No inhalation of Salmeterol.
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 or diagnosed primary lung cancer.
2)FEV1.0/FVC < 0.70, assessed by spirometry.
3)Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria I-III.
4)Modified Medical Research Council (MRC) score =<1.
5)Resectable cancer lesion by single lobectomy.
6)No previous treatment of COPD or asthma.
7)No past history of pulmonary resection.
8)Patients being able to stop smoking at the time of the registry to this trial.
9)Adequate organ function tolerable for the general anesthesia.
10)Capable for inhalation.
11)Age of 20 years or older.
12)ECOG performance status: 0, 1
13)Written informed consent to participate.
Key exclusion criteria
1)Median sternotomy.
2)Combined resection of the chest wall.
3)Active infection.
4)Active double cancer.
5)Current or previous history of severe heart diseases or cerebrovascular disases. Uncontrolled diabetes mellitus or hypertension. Interstitial pneumonia. Arrhythmia requiring antiarrhythmic continuously. Renal dysfunction necessitating blood purification therapy.
6)Patients with psychiatric disease.
7)Patients requiring systemic steroids medication.
8)Pregnant and lactating female, female who has possibility of pregnancy.
9)Past history of drug allergy.
10)Hypokalemia.
11)Patients who were judged inappropriate to enter this trial by physician.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taichiro Goto |
Organization
Yamanashi Prefectural Central Hospital
Division name
General Thoracic Surgery
Zip code
Address
1-1-1 Fujimi, Kofu-shi, Yamanashi 400-8506, Japan
TEL
055-253-7111
taichiro@1997.jukuin.keio.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taichiro Goto |
Organization
Yamanashi Prefectural Central Hospital
Division name
General Thoracic Surgery
Zip code
Address
1-1-1 Fujimi, Kofu-shi, Yamanashi 400-8506, Japan
TEL
055-253-7111
Homepage URL
taichiro@1997.jukuin.keio.ac.jp
Sponsor or person
Institute
Yamanashi Prefectural Central Hospital
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
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 25 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 05 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 24 | Day |
Last modified on
| 2020 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016701
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
