UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of irinotecan and amrubicin for relapsed non-small-cell lung cancer
Acronym	Irinotecan and amrubicin for relapsed non-small-cell lung cance
Scientific Title	Phase II study of irinotecan and amrubicin for relapsed non-small-cell lung cancer
Scientific Title:Acronym	Irinotecan and amrubicin for relapsed non-small-cell lung cance
Region	Japan

Condition
Condition	Relapsed non-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 irinotecan 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 NSCLC No prior surgery, chemotherapy, or radiotherapy Age ≤ 75 and ≥20 ECOG performance status 0 or 1 Measurable disease adequate bone marrow, lung, hepatic, and renal function 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://informahealthcare.com/doi/abs/10.3109/0284186X.2011.648342
Number of participants that the trial has enrolled
Results	Combination chemotherapy with irinotecan and amrubicin is effective in patients with NSCLC but showed moderate toxicities in second- or third-line settings.
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 12 Month 01 Day
Date of closure to data entry	2012 Year 01 Month 01 Day
Date trial data considered complete	2012 Year 01 Month 01 Day
Date analysis concluded	2012 Year 01 Month 01 Day

Other
Other related information

Management information
Registered date	2005 Year 09 Month 08 Day
Last modified on	2012 Year 03 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000193

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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