UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008189 |
|---|---|
| Receipt number | R000008829 |
| Scientific Title | Feasibility study of carboplatin, paclitaxel and bevacizumab in advanced non-squamous non-small-cell lung cancer with idiopathic interstitial pneumonias |
| Date of disclosure of the study information | 2012/06/18 |
| Last modified on | 2018/08/19 09:41:31 |
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Basic information
Public title
Feasibility study of carboplatin, paclitaxel and bevacizumab in advanced non-squamous non-small-cell lung cancer with idiopathic interstitial pneumonias
Acronym
Feasibility study of carboplatin, paclitaxel and bevacizumab in advanced non-squamous non-small-cell lung cancer with idiopathic interstitial pneumonias
Scientific Title
Feasibility study of carboplatin, paclitaxel and bevacizumab in advanced non-squamous non-small-cell lung cancer with idiopathic interstitial pneumonias
Scientific Title:Acronym
Feasibility study of carboplatin, paclitaxel and bevacizumab in advanced non-squamous non-small-cell lung cancer with idiopathic interstitial pneumonias
Region
| Japan |
Condition
Condition
Advanced non-squamous non-small-cell lung cancer with idiopathic interstitial pneumonias
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety and efficacy of carboplatin, paclitaxel and bevacizumab in patients with advanced non-squamous non-small-cell lung cancer with idiopathic interstitial pneumonias
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
safety (frequency of acute exacerbation of interstitial pneumonias)
Key secondary outcomes
progression-free survival, overall survival, response rate, time to response, frequency of of acute exacerbation of interstitial pneumonias by CTCAE v4.03 grades
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
chemotherapy(carboplatin, paclitaxel and bevacizumab)
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
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Pathologically confirmed non-squamous non-small-cell lung cancer
2.Clinical stage IIIB, IV or post-operative recurrence
3.Chemotherapy naive patients (permit using picibanil for pleurodesis)
4.Stable idiopathic interstitial pneumonia confirmed by high resolution chest CT(taking predonine less than 0.25mg/kg/day or 10mg/day can be allowed)
5.ECOG Performance status 0-1
6.Age over 20 -74 years.
7.Adequate organ function
8.Radiation therapy within 14 days prior to enrollment, major surgery within 28 days prior to enrollment, minor surgery within 7 days prior to enrollment, blood transfusion or administration of hematopoietic factor within 14 days prior to enrollment.
9. Life expectancy > 3 months
10. Signed informed consent
Key exclusion criteria
1.Acute or subacute idiopathic interstitial pneumonia
2.Being suspected or experienced acute exacerbation of idiopathic interstitial pneumonia.
3.Receiving immunosuppressants except for predonine
4.Having collagen diseases
5.Having central nervous system (CNS) metastases
6.History of gross hemoptysis (2.5ml or more) or severe hemosputum (reciving hemostatic drug)
7.Evidence of tumor invading large vessel, trachea or main bronchus on imaging
8.Patients who have received a radiation therapy in chest
9.Having an uncontrolled infection
10.Having a fever (more than 38 degrees
(Celsius))
11.Having severe complications
12.Having massive ascites, pleural effusion or pericardial effusion
13.Active concomitant malignancy without evidence of recurrence within 5 years
14.Having severe drug allegy
15.Evidence of gastrointestinal bleeding, intestinal obstruction and gastrointestinal ulceration
16.History or evidence of uncontrollable gastrointestinal ulceration or gastrointestinal perforation (within 1 year)
17.Having a tendency to bleed. Receiving anticoagulant drug (except Aspirin under 324mg/day).
18.Having a schedule of operations
19.Pulmonary tumor with the cavity (more than 1cm)
20.History of pregnancy or lactation,
21.History of myocardial infarction or cerebral infarction (within 1 year)
22.Haiving hypersensitivity to carboplatin, paclitaxel and bevacizumab, Cremophor E or alchol.
23.Using a home oxygen therapy
24.Decision of ineligibility by the attending physician
Target sample size
27
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuma Kishi |
Organization
Toranomon Hospital
Division name
Respiratory Medicine, Respiratory Center
Zip code
Address
2-2-2 Toranomon, Minato-ku, Tokyo, Japan, 105-8470
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuji Minegishi |
Organization
Nippon Medical School,
Division name
Division of Pulmonary Medicine, Infectious Disease, and Oncology, Department of Internal Medicine
Zip code
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, Japan, 113-8602
TEL
Homepage URL
Sponsor or person
Institute
The Ministry of Health, Labour and Welfare of Japan awarded to the Study Group on Diffuse Pulmonary Disorders, Scientific Research/Research on intractable diseases
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Health, Labour and Welfare of Japan awarded to the Study Group on Diffuse Pulmonary Disorders, Scientific Research/Research on intractable diseases
Organization
Division
Category of Funding Organization
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
| 2012 | Year | 06 | Month | 18 | 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
Completed
Date of protocol fixation
| 2012 | Year | 04 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 06 | Month | 17 | Day |
Last modified on
| 2018 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008829
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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