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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000130
Receipt No. 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

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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
Institute Okayama Lung Cancer Study Group
Institute
Department

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
URL(English) https://upload.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


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