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
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
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
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
