UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011055
Receipt number R000012939
Scientific Title Phase II study of amrubicin monotherapy for treating elderly and poor-risk patients with small-cell lung cancer.
Date of disclosure of the study information 2013/07/01
Last modified on 2016/06/27 13:24:12

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Basic information

Public title

Phase II study of amrubicin monotherapy for treating elderly and poor-risk patients with small-cell lung cancer.

Acronym

Phase II study of amrubicin monotherapy for treating elderly and poor-risk patients with small-cell lung cancer.

Scientific Title

Phase II study of amrubicin monotherapy for treating elderly and poor-risk patients with small-cell lung cancer.

Scientific Title:Acronym

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


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



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

1st name
Middle name
Last name Satoshi Igawa

Organization

Kitasato University School of Medicine

Division name

Department of Respiratory Medicine

Zip code


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

1st name
Middle name
Last name Satoshi Igawa

Organization

Kitasato University School of Medicine

Division name

Department of Respiratory Medicine

Zip code


Address

1-15-1, Kitasato, Minami-ku, Sagamihara-city, Kanagawa,

TEL

81-42-778-8506

Homepage URL


Email

igawa@kitasato-u.ac.jp


Sponsor or person

Institute

Kitasato University School of Medicine
Department of Respiratory Medicine

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

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


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


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

2011 Year 01 Month 13 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012939


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name