UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006622 |
|---|---|
| Receipt number | R000007826 |
| Scientific Title | Phase II study of Carboplatin, weekly Paclitaxel and Bevacizumab in elderly patients with advanced non-squamous non-small-cell lung cancer (NEJ 016) |
| Date of disclosure of the study information | 2011/10/28 |
| Last modified on | 2017/05/01 21:10:25 |
* 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
Phase II study of Carboplatin, weekly Paclitaxel and Bevacizumab in elderly patients with advanced non-squamous non-small-cell lung cancer (NEJ 016)
Acronym
Phase II study of Carboplatin, weekly Paclitaxel and Bevacizumab in elderly patients with advanced non-squamous non-small-cell lung cancer (NEJ 016)
Scientific Title
Phase II study of Carboplatin, weekly Paclitaxel and Bevacizumab in elderly patients with advanced non-squamous non-small-cell lung cancer (NEJ 016)
Scientific Title:Acronym
Phase II study of Carboplatin, weekly Paclitaxel and Bevacizumab in elderly patients with advanced non-squamous non-small-cell lung cancer (NEJ 016)
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of Weekly Paclitaxel, Carboplatin and Bevacizumab in patients with 70 years or older non-squamous NSCLC.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Safety, Disease control rate, Progression free survival, Overall survival, Biomarker analysis, correlation of efficacy with EGFR gene mutation
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
Bevacizumab, Paclitaxel, Carboplatin
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) StageIIIB/IV or postoperative recurrence Non-small cell lung cancer and Non-Squamous cell carcinoma proven by histology and/or cytology
2) No prior chemotherapy
3) 70 years or older
4) ECOG-PS 0 or 1
5) At least one or more measurable lesion by RECIST.
6) Adequate organ function
7) Interval
-Palliative radiotherapy >2wks
-Surgery >4wks
-thoracic drainage>1wks
-biopsy with dissection, indwelling port >1wks
-blood transfusion >1wks
8) Life expectancy more than three months.
9) Written Informed Consent
Key exclusion criteria
1) History of hemoptysis
2) High risk of bleeding or thrombus events
3) History of anticoagulant within 10 days before enrollment
4) Grade 2 or worse neuropathy
5) Uncontrollable hypertension
6) Symptomatic brain metastasis
7) Uncontrollable pleural effusion or peritoneal effusion
8) Scheduled operation
9) Severe complications
10) Severe infection
11) History of active double cancer
12) No intention to birth control
13) Unstable psychic disorder
14) History of treatment drug
15) History of severe allergic reaction with platinum drug or monoclonal antibody
16) History of allergic reaction with taxan drug, polyoxyethylene or alcohol.
17) Decision of ineligibility by a physician.
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | HIrohisa Yoshizawa |
Organization
Niigata University Medical & Dental Hospital
Division name
Bioscience Medical Research Center
Zip code
Address
1-754 Asahimachi-dori, Chuo-ku, Niigata 951-8510, Japan
TEL
025-227-2517
hy0522@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoru Miura |
Organization
Niigata University Medical & Dental Hospital
Division name
Division of Respiratory Medicine
Zip code
Address
1-754 Asahimachi-dori, Chuo-ku, Niigata 951-8510, Japan
TEL
025-227-2200
Homepage URL
miusat1118@med.niigata-u.ac.jp
Sponsor or person
Institute
North East Japan Study Group
Institute
Department
Personal name
Funding Source
Organization
North East Japan Study Group
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
| 2011 | Year | 10 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/28150074
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
| 2011 | Year | 09 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2015 | Year | 06 | Month | 12 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 27 | Day |
Last modified on
| 2017 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007826
