UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024610 |
|---|---|
| Receipt number | R000028266 |
| Scientific Title | Phase 2 prospective study of the efficacy of nab-paclitaxel, carboplatin and bevacizumab for the treatment of stage 3B/4 non-squamous cell and non-small cell lung cancer |
| Date of disclosure of the study information | 2016/11/01 |
| Last modified on | 2018/04/30 15:08:25 |
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Basic information
Public title
Phase 2 prospective study of the efficacy of nab-paclitaxel, carboplatin and bevacizumab for the treatment of stage 3B/4 non-squamous cell and non-small cell lung cancer
Acronym
Phase 2 study of nab-paclitaxel, carboplatin and bevacizumab for the treatment of non-squamous and non-small cell lung cancer
Scientific Title
Phase 2 prospective study of the efficacy of nab-paclitaxel, carboplatin and bevacizumab for the treatment of stage 3B/4 non-squamous cell and non-small cell lung cancer
Scientific Title:Acronym
Phase 2 study of nab-paclitaxel, carboplatin and bevacizumab for the treatment of non-squamous and non-small cell lung cancer
Region
| Japan |
Condition
Condition
Non-squamous cell and non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate efficacy and safety of the combination therapy, nab-paclitaxel, carboplatin and bevacizumab,in patients with non-squamous cell and non-small cell advanced lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progressin free survival after the first line chemotherapy, the combination of nab-paclitaxel, carboplatin and bevacizumab.
Key secondary outcomes
Overall survival,progressin free survival after the maintenance therapy, response rate, and safety
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
The combination therapy of nab-paclitaxel, carboplatin 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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Non-squamous cell and non-small cell lung cancer
2)Stage 3B or 4
3) Evaluable lesions
4) 20~74 years old
5) PS 0~1
6) No severe organ dysfunction and laboratory data fulfill the standards.
7) Three months and more survival is expected.
8) Informed consent
9) One regimen of EGFR-TKI or ALK-TKI is permitted.
Key exclusion criteria
1) Brain metastasis accompnied by significant symptoms.
2) Hemoptysis
3) Allergy or hypersensitibity against the medicines in this trial or albumin.
4) Peripheral neuropathy (grade 2 or more) before the treatment.
5) Uncontrolled effusion.
6) Palliative radiation within 2 weeks.
7) Operation within 4 weeks.
8) Active double cancer
9) High body temperature (38 degrees Celsius and more).
10) Severe complications.
11) Anti-coagulation therapy
12) Pregnant woman
13) HBs antigen positive
14) The subjects whom the doctor excluded.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tamotsu Ishizuka |
Organization
Faculty of Medical Sciences, University of Fukui
Division name
Third Department of Internal Medicine
Zip code
Address
23-3 Matsuoka-Shimoaizuki, Eiheiji-cho, Yoshida-gun. Fukui 910-1193
TEL
0776-61-8355
tamotsui@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tamotsu Ishizuka |
Organization
Faculty of Medical Sciences, University of Fukui
Division name
Third Department of Internal Medicine
Zip code
Address
23-3 Matsuoka-Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui 910-1193
TEL
0776-61-8355
Homepage URL
tamotsui@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui
Institute
Department
Personal name
Funding Source
Organization
University of Fukui
Organization
Division
Category of Funding Organization
Other
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
福井大学医学部附属病院（福井県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 11 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 10 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | 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
| 2016 | Year | 10 | Month | 28 | Day |
Last modified on
| 2018 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028266
