UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008970
Receipt number R000010520
Scientific Title Randomized phase II trial comparing carboplatin plus irinotecan with carboplatin plus amrubicine for extensive disease small-cell lung cancer
Date of disclosure of the study information 2012/10/01
Last modified on 2015/03/24 12:49:19

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Basic information

Public title

Randomized phase II trial comparing carboplatin plus irinotecan with carboplatin plus amrubicine 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 trial comparing carboplatin plus irinotecan with carboplatin plus amrubicine 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

Small-cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of above 2 regimen for ED-SCLC

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Objective 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 plus irinotecan

Interventions/Control_2

carboplatin plus amrubicine

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. Histologically or cytologically confirmed SCLC.
2. Chemo-naive
3. Stage IIIB, IV, or post-operative relapse
4. PS0-2
5. Adequete organ functions
6. Written informed concent

Key exclusion criteria

1. Severe co-morbidities
2. Symptomatic brain metastasis
3. Not appropriate for clinical trial decided by the attending physician

Target sample size

70


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Naoto Morikawa

Organization

Iwate Medical University

Division name

Division of Pulmonary Medicine, Allergy, and Rheumatology

Zip code


Address

19-1 Uchimaru, Morioka, Iwate 020-8505

TEL

+81-19-651-5111

Email

carcinoma@nifty.com


Public contact

Name of contact person

1st name
Middle name
Last name Akira Inoue

Organization

North-Japan lung cancer group

Division name

Office

Zip code


Address

1-1, Seiryocho, Aobaku, Sendai

TEL

+81-22-717-8539

Homepage URL


Email

akinoue@idac.tohoku.ac.jp


Sponsor or person

Institute

North-Japan lung cancer group

Institute

Department

Personal name



Funding Source

Organization

North-Japan lung cancer group

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

2012 Year 10 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


Anticipated trial start date

2009 Year 12 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

2012 Year 09 Month 24 Day

Last modified on

2015 Year 03 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010520


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name