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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000026706
Receipt No. 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

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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
Email 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
Email ty14401@kchnet.or.jp

Sponsor
Institute Kurashiki Central Hospital
Department of Respiratory medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030659

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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