UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015144 |
|---|---|
| Receipt number | 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 11:39:42 |
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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
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
uchino@koto.kpu-m.ac.jp
Sponsor or person
Institute
Fukuoka University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017570
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
