UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of amrubicin monotherapy for treating elderly and poor-risk patients with small-cell lung cancer.
Title of the study (Brief title)	Phase II study of amrubicin monotherapy for treating elderly and poor-risk patients with small-cell lung cancer.
Region	Japan

Condition
Condition	small cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	evaluating the efficacy and safety of amrubicin monotherapy for elderly or poor risk patients with small cell lung cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Response rate
Key secondary outcomes	Progression free survival, Overall survival,Safety

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Amrubicin monotherapy
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	(1)histological or cytological confirmation of SCLC; (2) confirmation of extensive disease based on results of chest X-ray, computed tomography (CT) of the chest and abdomen, and other procedures, including magnetic resonance imaging (MRI) of the head, bone scintiscan, and positron emission tomography (PET) or combined PET/CT; (3) age 75 years or older, or performance status (PS) of 2 or more according to the Eastern Cooperative Oncology Group (ECOG) scale; (4) adequate bone marrow, hepatic, and renal function; (5) written informed consent.
Key exclusion criteria	Patients were ineligible if they had serious infectious diseases or other severe complications (heart disease, pulmonary fibrosis/interstitial pneumonia, or uncontrollable diabetes); had massive pleural or pericardial effusion, or ascitic fluid; had symptomatic brain metastases; had active concurrent malignancies; were lactating or pregnant women or hoped to become pregnant; had a history of a drug allergy; or had other medical problems severe enough to prevent compliance with the protocol. Prior amrubicin chemotherapy was not allowed.
Target sample size	34

Research contact person
Name of lead principal investigator	Satoshi Igawa
Organization	Kitasato University School of Medicine
Division name	Department of Respiratory Medicine
Address	Kitasato, Minami-ku, Sagamihara-city, Kanagawa, Japan
TEL	81-42-778-8506
Email	igawa@kitasato-u.ac.jp

Public contact
Name of contact person	Satoshi Igawa
Organization	Kitasato University School of Medicine
Division name	Department of Respiratory Medicine
Address	1-15-1, Kitasato, Minami-ku, Sagamihara-city, Kanagawa,
TEL	81-42-778-8506
Homepage URL
Email	igawa@kitasato-u.ac.jp

Sponsor
Institute	Kitasato University School of Medicine Department of Respiratory Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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	北里大学病院(神奈川県)

Other administrative information
Date of disclosure of the study information	2013 Year 07 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 01 Month 13 Day
Anticipated trial start date	2011 Year 02 Month 01 Day
Last follow-up date	2015 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 06 Month 27 Day
Last modified on	2016 Year 06 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012939