UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014544 |
|---|---|
| Receipt number | R000016917 |
| Scientific Title | Phase I/II study of Carboplatin plus Nab-Paclitaxel in patients with advanced non-small-cell lung cancer and a performance status of 2 |
| Date of disclosure of the study information | 2014/07/14 |
| Last modified on | 2019/01/15 11:25:40 |
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Basic information
Public title
Phase I/II study of Carboplatin plus Nab-Paclitaxel in patients with advanced non-small-cell lung cancer and a performance status of 2
Acronym
Phase I/II study of Carboplatin plus Nab-Paclitaxel in patients with advanced non-small-cell lung cancer and a performance status of 2
Scientific Title
Phase I/II study of Carboplatin plus Nab-Paclitaxel in patients with advanced non-small-cell lung cancer and a performance status of 2
Scientific Title:Acronym
Phase I/II study of Carboplatin plus Nab-Paclitaxel in patients with advanced non-small-cell lung cancer and a performance status of 2
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 feasibility and efficacy of Carboplatin plus Nab-Paclitaxel in chemotherapy-naive patients with advanced non-small-cell lung cancer and a performance status of 2
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Phase I: Dose limiting toxicity
Phase II: Progression free survival
Key secondary outcomes
Phase I: Adverse event, Response rate
Phase II: Adverse event, Response rate, Overall survival
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
Carboplatin plus Nab-Paclitaxel
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) Pathologically confirmation of non-small-cell lung cancer
2) Stage IIIB/IV and chemo-naive non-small-cell lung cancer
3) ECOG PS 2
4) Evaluable lesions
5) Aged 20 or more
6) Adequate organ functions
7) Expected survival over 90 days
8) Written informed consent
Key exclusion criteria
1) Symptomatic brain metastasis
2) Interstitial pneumonia with usual interstitial pneumonia pattern on chest CT
3) Grade 2 or more peripheral sense neuropathy
4) With uncontrolled pleural effusion, ascites or pericardial effusion
5) Treated with palliative radiotherapy within the past two weeks
6) Active concomitant malignancy
7) Severe complication
8) HBs antigen positive
9) Previous severe drug allergy
10) Continuous systemic administration of steroid
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiaki Takahashi |
Organization
Shizuoka cancer center
Division name
Division of Thoracic Oncology
Zip code
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL
(+81)055-989-5222
t.takahashi@scchr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhisa Nakashima |
Organization
Shizuoka cancer center
Division name
Division of Thoracic Oncology
Zip code
Address
1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
TEL
(+81)055-989-5222
Homepage URL
ka.nakashima@scchr.jp
Sponsor or person
Institute
Shizuoka cancer center
Institute
Department
Personal name
Funding Source
Organization
None
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
静岡県立静岡がんセンター（静岡県）
和歌山県立医科大学病院（和歌山県）
倉敷中央病院（岡山県）
広島市立広島市民病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 14 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 06 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 14 | 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 | 07 | Month | 13 | Day |
Last modified on
| 2019 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016917
| 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 |
