UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026706 |
|---|---|
| Receipt number | R000030659 |
| Scientific Title | Carboplatin with nab-paclitaxel as first-line therapy in patients with advanced non-small-cell lung cancer and idiopathic interstitial pneumonias |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2017/09/29 18:50:46 |
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Basic information
Public title
Carboplatin with nab-paclitaxel as first-line therapy in patients with advanced non-small-cell lung cancer and idiopathic interstitial pneumonias
Acronym
Carboplatin with nab-paclitaxel as first-line therapy in patients with advanced non-small-cell lung cancer and idiopathic interstitial pneumonias
Scientific Title
Carboplatin with nab-paclitaxel as first-line therapy in patients with advanced non-small-cell lung cancer and idiopathic interstitial pneumonias
Scientific Title:Acronym
Carboplatin with nab-paclitaxel as first-line therapy in patients with advanced non-small-cell lung cancer and idiopathic interstitial pneumonias
Region
| Japan |
Condition
Condition
non-small-cell lung cancer with idiopathic interstitial pneumonias
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of carboplatin with nab-paclitaxel therapy in patients with advanced non-small-cell lung cancer and idiopathic interstitial pneumonias
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
response rate (not necessarily with confirmation)
Key secondary outcomes
progression free survival, overall survival, time to treatment failure, response rate with confirmation, adverse events
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 with 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) chemotherapy-naive histologically or cytologically
confirmed stage IIIA,B/IV (TNM classification 8th version)or postoperative recurrent NSCLC
2) without history of radiotherapy for primary tumor
3) more than and equal to 20 years old
4) diagnosed with idiopathic interstitial pneumonias
5) with measurable lesions of tumors
6) ECOG performance status of 0-2
7) with no highly disabled organ functions
Key exclusion criteria
1) with interstitial pneumonias secondary to other conditions
2) with history of acute exacerbations of interstitial pneumonias within 3 months
3) with history of subacute exacerbations of interstitial pneumonias within 3 months
4) with usage of immunosuppressants
5) with peripheral neuropathy with Grade 2-4
6) with allergy to carboplatin, albumin, or taxane-based anticancer agents
7) with active infectious diseases
8) with active double cancers
9) with clinically important complications
10) with positivity of HBs antigen
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihide Yokoyama |
Organization
Kurashiki Central Hospital
Division name
Department of Respiratory medicine
Zip code
Address
1-1-1 Miwa Kurashiki Okayama Japan
TEL
086-422-0210
tk15127@kchnet.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihide Yokoyama |
Organization
Kurashiki Central Hospital
Division name
Department of Respiratory medicine
Zip code
Address
1-1-1 Miwa Kurashiki Okayama Japan
TEL
086-422-0210
Homepage URL
ty14401@kchnet.or.jp
Sponsor or person
Institute
Kurashiki Central Hospital
Department of Respiratory medicine
Institute
Department
Personal name
Funding Source
Organization
None.
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
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
倉敷中央病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 02 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | 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
| 2017 | Year | 03 | Month | 26 | Day |
Last modified on
| 2017 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030659
