UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000024610
Receipt No. 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

* 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 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
Email 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
Email tamotsui@u-fukui.ac.jp

Sponsor
Institute University of Fukui
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028266

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.