UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008476
Receipt number R000008530
Scientific Title A blood-based study to predict the efficacy of carboplatin plus pemetrexed treatment on nonsquamous non-small cell lung cancer
Date of disclosure of the study information 2012/07/25
Last modified on 2017/01/21 11:22:49

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Basic information

Public title

A blood-based study to predict the efficacy of carboplatin plus pemetrexed treatment on nonsquamous non-small cell lung cancer

Acronym

A blood-based study to predict the efficacy of carboplatin plus pemetrexed treatment on nonsquamous non-small cell lung cancer

Scientific Title

A blood-based study to predict the efficacy of carboplatin plus pemetrexed treatment on nonsquamous non-small cell lung cancer

Scientific Title:Acronym

A blood-based study to predict the efficacy of carboplatin plus pemetrexed treatment on nonsquamous non-small cell lung cancer

Region

Japan


Condition

Condition

nonsquamous non-small cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

to identify blood-based biomarkers to predict the efficacy of carboplatin plus pemetrexed on nonsquamous non-small cell lung cancer

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

proteomics
microRNA analysis

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

Patients intended to be treated with carboplatin and pemetrexed are eligible for this study if they meet the following criteria;
1) Patients with pathologically proven nonsquamous non-small cell lung cancer
2) Patients with stage IIIA, IIIB or IV who are not candidates for curative radiotherapy or surgery.
3) previously untreated patients
4) Patient who has at least one or more measurable lesion by RECIST.
5) Patients aged 20 years or older.
6) Adequate organ function.
7) Patients who are considered to survive for more than 3 months.
8) Written informed consent.

Key exclusion criteria

1) Previous radiotherapy to primary lung cancer.
2) With active double cancer.
3) Patients whose participation in the trial is judged to be inappropriate due to phychological disorders.

Target sample size

350


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshinori Hasegawa

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Respiratory Medicine

Zip code


Address

65 Tsurumai-cho, Showo-ku, Nagoya-City, Aichi, 466-8550, Japan

TEL

052-744-2167

Email

yhasega@med.nagoya-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masashi Kondo, Mitsuo Sato, Masahiro Morise, Tetsunari Hase

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Respiratory Medicine

Zip code


Address

65 Tsurumai-cho, Showo-ku, Nagoya-City, Aichi, 466-8550, Japan

TEL

052-744-2167

Homepage URL

http://cjlsg.umin.jp/index.html

Email

cjlsg@med.nagoya-u.ac.jp


Sponsor or person

Institute

Central Japan Lung Study Group (CJLSG)

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

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



Other administrative information

Date of disclosure of the study information

2012 Year 07 Month 25 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

No longer recruiting

Date of protocol fixation

2012 Year 02 Month 28 Day

Date of IRB


Anticipated trial start date

2012 Year 08 Month 01 Day

Last follow-up date

2017 Year 03 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This study is a prospective observational study.


Management information

Registered date

2012 Year 07 Month 19 Day

Last modified on

2017 Year 01 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008530


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name