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
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
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
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
