UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002615
Receipt number R000003192
Scientific Title Randomized phase II study of carboplatin plus irinotecan versus carboplatin plus amrubicin for extensive disease small cell lung cancer
Date of disclosure of the study information 2009/11/01
Last modified on 2020/02/03 10:21:42

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Basic information

Public title

Randomized phase II study of carboplatin plus irinotecan versus carboplatin plus amrubicin for extensive disease small cell lung cancer

Acronym

Randomized phase II of CBDCA+CPT vs CBDCA+AMR for ED-SCLC

Scientific Title

Randomized phase II study of carboplatin plus irinotecan versus carboplatin plus amrubicin for extensive disease small cell lung cancer

Scientific Title:Acronym

Randomized phase II of CBDCA+CPT vs CBDCA+AMR for ED-SCLC

Region

Japan


Condition

Condition

Extensive disease small cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

to select the better treatment for phase III trial

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

Parallel

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

carboplatin + irinotecan

Interventions/Control_2

carboplatin + amrubicin

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. Cytologically or histologically proven small cell lung caner
2. Chemotherapy-naive extensive disease small cell lung cancer
3. With performance status 0-2
4. With appropriate organ function
5. With mesurable lesion
6. With life expectancy > 2 months
7. With written informed consent

Key exclusion criteria

1. With serirous comprications such as infection, heart disease, lung fibrosis.
2. With symptomatic brain metastasis or massive effusion
3. With active other malignancies
4. Pregnant women

Target sample size

70


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akira Inoue

Organization

Tohoku University Hospital

Division name

Respiratory medicine

Zip code


Address

1-1, Seiryomachi, Aobaku, Sendai

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

North Japan Lung Cancer Study Group

Division name

Office

Zip code


Address


TEL


Homepage URL


Email

akinoue@idac.tohoku.ac.jp


Sponsor or person

Institute

Tohoku University Hospital

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


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

2009 Year 11 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

Completed

Date of protocol fixation

2009 Year 06 Month 24 Day

Date of IRB

2009 Year 10 Month 27 Day

Anticipated trial start date

2009 Year 11 Month 01 Day

Last follow-up date

2011 Year 09 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2009 Year 10 Month 12 Day

Last modified on

2020 Year 02 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003192


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name