UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011669 |
|---|---|
| Receipt number | R000013643 |
| Scientific Title | Phase II study of the 2nd line Nab-PTX/CBDCA combination therapy for advanced non-small cell lung cancer which is previously treated with platinum-based chemotherapy |
| Date of disclosure of the study information | 2013/09/06 |
| Last modified on | 2013/09/06 15:24:15 |
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Basic information
Public title
Phase II study of the 2nd line Nab-PTX/CBDCA combination therapy for advanced non-small cell lung cancer which is previously treated with platinum-based chemotherapy
Acronym
Phase II Study of Nab-PTX/CBDCA for NSCLC previously treated with platinum
Scientific Title
Phase II study of the 2nd line Nab-PTX/CBDCA combination therapy for advanced non-small cell lung cancer which is previously treated with platinum-based chemotherapy
Scientific Title:Acronym
Phase II Study of Nab-PTX/CBDCA for NSCLC previously treated with platinum
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the efficacy and safety of Nab-PTX plus CBDCA as 2nd-line therapy in patients with stage IIIB/IV non-small-cell lung cancer previously treated with platinum-based chemotherapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Response rate
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 at the dose of 100mg/m2 (day 1, 8, 15) and carboplatin at the dose of area under curve 5 (day 1) are administered every 4 weeks. Treatment can be continued unless PD or toxicity that is not tolerable is found.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Definitively diagnosed with non-small cell lung cancer by the specimens histologically or cytologically.
2) Clinical Stage IIIB which curative radiotherapy is not indicated, IV
3) Prior chemotherapy is 1 regimen, which is platinum-based combination regimen (exclude EGFR-TKI and ALK inhibitor)
4) Age of 20 to 79 years
5) Without active cancer other than NSCLC
6) At least one measurable lesion
7) With adequate organ function
neutrophil count => 1,500/mm^3
platelet => 100,000/mm^3
hemoglobin => 9.0g/dL
AST/ALT < 2.5 times less than ULN
T.Bil <= 1.5mg/dL
serum creatinine <= 1.5mg/dL
ECG: without clinically problematic abnorbomalities
Peripheral neuropathy <= Grade 1
8) Life expectancy of at least 3 months
9) ECOG performance status 0 or 1
10) With written informed consent
Key exclusion criteria
1) Symptomatic brain metastasis
2) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males that are currently attempting to produce a pregnancy
3) With active double cancer or multicentric cancer
4) Treated with radiotherapy within the past four weeks.
5) With a history of the treatment with taxane.
6) With clinically important complications.
7) Interstitial pneumonia or pulmonary fibrosis becomes the clinical problem
8) With pleural effusion or pericardial effusion accumulates which need drainage
9) With the history of hypersensivity for nab-paclitaxel, CBDCA
10) Main organs had a serious medical risk factor, and the physicians judged treatment not to be safe.
11) Physician concludes that the patient's participation in this trial is inappropriate
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiki Ishii |
Organization
Dokkyo Medical University School of Medicine
Division name
Pulmonary Medicine and Clinical Immunology
Zip code
Address
880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi, 321-0293 JAPAN
TEL
0282-87-2151
ishiiysk@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiki Ishii |
Organization
Dokkyo Medical University
Division name
Pulmonary Medicine and Clinical Immunology
Zip code
Address
880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi, 321-0293 JAPAN
TEL
0282-87-2151
Homepage URL
ishiiysk@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
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
Tochigi-kitakan Thoracic Oncology Research Organization (TOTORO)
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
| 2013 | Year | 09 | Month | 06 | 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
| 2013 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 06 | 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
| 2013 | Year | 09 | Month | 06 | Day |
Last modified on
| 2013 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013643
