UMIN-CTR Clinical Trial

Unique ID issued by UMIN C000000130
Receipt number R000000179
Scientific Title Phase II study of topotecan and amrubicin for metastatic or relapsed small-cell lung cancer
Date of disclosure of the study information 2005/09/12
Last modified on 2011/03/07 10:01:17

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Basic information

Public title

Phase II study of topotecan and amrubicin for metastatic or relapsed small-cell lung cancer

Acronym

Topotecan and amrubicin for metastatic or relapsed small-cell lung cancer

Scientific Title

Phase II study of topotecan and amrubicin for metastatic or relapsed small-cell lung cancer

Scientific Title:Acronym

Topotecan and amrubicin for metastatic or relapsed small-cell lung cancer

Region

Japan


Condition

Condition

Metastatic or relapsed small-cell lung cancer

Classification by specialty

Pneumology Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate (i) efficacy and (ii) safety of the combination chemotherapy.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

Primary outcomes

Response rate

Key secondary outcomes

Adverse events, overall survival, progression-free survival


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Combination chemotherapy of topotecan and amrubicin

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

75 years-old >=

Gender

Male and Female

Key inclusion criteria

Histologically and/or cytologically proven SCLC
No prior surgery, chemotherapy or radiotherapy, or relapsed
Age ≤ 75 and ≥20
ECOG performance status 0 or 1
Measurable disease
adequate bone marrow, lung, hepatic, and renal function
chemo-naïve or no prior therapy within four weeks
Written informed consent

Key exclusion criteria

Active concomitant malignancy
Active interstitial pneumonia
Massive effusions
Unstable angina, recent myocardial infarction
Uncontrolled diabetes
Severe active infection
Other severe complications
Pregnant or lactating women
Inappropriate condition for this study judged by physicians.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mitsune Tanimoto

Organization

Okayama University Hospital

Division name

Hematology, Oncology, Respiratory Medicine

Zip code


Address

2-5-1 Shikata-cho, Okayama 700-8558

TEL

086-235-7227

Email



Public contact

Name of contact person

1st name
Middle name
Last name Katsuyuki Hotta

Organization

Okayama Lung Cancer Study Group Coordinating Office

Division name

Department of Respiratory Medicine, Okayama University Hospital

Zip code


Address

2-5-1 Shikata-cho, Okayama 700-8558

TEL

086-235-7227

Homepage URL


Email

khotta@md.okayama-u.ac.jp


Sponsor or person

Institute

Okayama Lung Cancer Study Group

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

2005 Year 09 Month 12 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.ncbi.nlm.nih.gov/pubmed/21334093

Number of participants that the trial has enrolled


Results

This phase II study showed the favorable efficacy and moderate safety profiles of a topotecan and amrubicin two-drug combination especially in relapsed patients with ED-SCLC.

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

2004 Year 03 Month 03 Day

Date of IRB


Anticipated trial start date

2004 Year 04 Month 01 Day

Last follow-up date

2009 Year 04 Month 01 Day

Date of closure to data entry

2010 Year 12 Month 01 Day

Date trial data considered complete

2010 Year 12 Month 01 Day

Date analysis concluded

2011 Year 01 Month 01 Day


Other

Other related information

Lung Cancer. 2011 Feb 17. [Epub ahead of print]


Management information

Registered date

2005 Year 09 Month 07 Day

Last modified on

2011 Year 03 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000179


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name