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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000015144
Receipt No. R000017570
Scientific Title Phase II study of Carboplatin + nab-Paclitaxel followed by nab-Paclitaxel with chemotherapy naive advanced Non- Small Cell Lung Cancer
Date of disclosure of the study information 2014/09/13
Last modified on 2018/01/26

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Basic information
Public title Phase II study of Carboplatin + nab-Paclitaxel followed by nab-Paclitaxel with chemotherapy naive advanced Non- Small Cell Lung Cancer
Acronym Phase II study of Carboplatin + nab-Paclitaxel followed by nab-Paclitaxel with chemotherapy naive advanced Non- Small Cell Lung Cancer
Scientific Title Phase II study of Carboplatin + nab-Paclitaxel followed by nab-Paclitaxel with chemotherapy naive advanced Non- Small Cell Lung Cancer
Scientific Title:Acronym Phase II study of Carboplatin + nab-Paclitaxel followed by nab-Paclitaxel with chemotherapy naive advanced Non- Small Cell Lung Cancer
Region
Japan

Condition
Condition Chemotherapy naive non-small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To evaluate the efficacy of nab-PTX+CBDCA followed by nab-PTX in patients with NSCLC.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Progression Free Survival
Key secondary outcomes

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 nab-Paclitaxel 100mg/sqm D1,8,15 + CBDCA AUC 6 D1:q4week*4cycles
nab-Paclitaxel 100mg/sqm D1,8,15:q4week
until PD
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Histologically or cytologically proven diagnosis of NSCLC that is locally advanced or metastatic
2) Female or male, 20 years of age or older
3) ECOG performance status 2 to 4
4) At least 1 measurable tumor lesion as per RECIST v1.1
5) Chemotherapy-naive patients
6) Adequate organ function
7) Signed and dated informed consent
Key exclusion criteria 1) Active severe comorbidity disease.
2) Interstitial pneumonia or pulmonary fibrosis on chest CT scans.
3) Patients with symptomatic Brain metastases.
4) Active concomitant malignancy.
5) Active infectious disease.
6) Pregnant or breast-feeding females.
7) Unstable psychic disorder.
8) Accepted continuous use of steroid.
9) Inappropriate patients for this study judged by the physicians.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kentaro Watanabe
Organization Fukuoka University School of Medicine
Division name Respiratory Medicine
Zip code
Address 7-45-1 Nanakuma, Jonanku, Fukuoka
TEL 092-801-1011
Email uchino@fukuoka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Junji Uchino
Organization Fukuoka University School of Medicine
Division name Respiratory Medicine
Zip code
Address 7-45-1 Nanakuma, Jonanku, Fukuoka
TEL 075-251-5513
Homepage URL
Email uchino@koto.kpu-m.ac.jp

Sponsor
Institute Fukuoka University School of Medicine
Institute
Department

Funding Source
Organization Fukuoka University School of Medicine, Respiratory Medicine
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
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

Other administrative information
Date of disclosure of the study information
2014 Year 09 Month 13 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 No longer recruiting
Date of protocol fixation
2014 Year 08 Month 27 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 27 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
2014 Year 09 Month 12 Day
Last modified on
2018 Year 01 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017570

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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