UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002617
Receipt number R000001507
Scientific Title Randomized PhaseII study of amrubicin vs platinum-doublet re-challenge for small cell lung cancer with sensitive relapse
Date of disclosure of the study information 2010/03/31
Last modified on 2015/10/13 18:35:25

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Basic information

Public title

Randomized PhaseII study of amrubicin vs platinum-doublet re-challenge for small cell lung cancer with sensitive relapse

Acronym

AMR vs Re-Platinum for Sensitive Relapsed SCLC

Scientific Title

Randomized PhaseII study of amrubicin vs platinum-doublet re-challenge for small cell lung cancer with sensitive relapse

Scientific Title:Acronym

AMR vs Re-Platinum for Sensitive Relapsed SCLC

Region

Japan


Condition

Condition

Small-Cell Lung Cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To compare the efficacy and safety of amrubicin with re-challange of platinum-doublet for sensitive relapased small-cell lung cancer

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

amrubicin

Interventions/Control_2

Re-challange of platinum-doublet

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

Sensitive relapased SCLC after platinum-based chemotherapy
ECOG performance status 0-2
Adequate organ function
With mesurable lesion
With written informed concent

Key exclusion criteria

Pre-treated with amrubicin
With severe co-morbidities
With symptomatic brain metastasis

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Akira Inoue

Organization

Tohoku University Hospital

Division name

Department of Respiratory Medicine

Zip code


Address

1-1, Seiryomachi, Aobaku, Sendai

TEL

+81-22-717-8539

Email

akinoue@idac.tohoku.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Akira Inoue

Organization

Tohoku University Hospital

Division name

Department of Respiratory Medicine

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

Tohoku University Hospital

Institute

Department

Personal name



Funding Source

Organization

Tohoku University Hospital

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

2010 Year 03 Month 31 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

2007 Year 10 Month 11 Day

Date of IRB


Anticipated trial start date

2008 Year 02 Month 01 Day

Last follow-up date

2011 Year 10 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

2015 Year 10 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001507


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name