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

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 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


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

Value
https://center6.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