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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002763
Receipt No. R000003129
Scientific Title Phase II study of Amrubicin in patients with Small-Cell Lung Cancer that is refractory or relapsed within 90 days of completing previous treatment (JCOG0901)
Date of disclosure of the study information 2009/11/13
Last modified on 2014/02/21

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Basic information
Public title Phase II study of Amrubicin in patients with Small-Cell Lung Cancer that is refractory or relapsed within 90 days of completing previous treatment (JCOG0901)
Acronym Phase II study of Amrubicin in patients with Small-Cell Lung Cancer that is refractory or relapsed within 90 days of completing previous treatment (JCOG0901)
Scientific Title Phase II study of Amrubicin in patients with Small-Cell Lung Cancer that is refractory or relapsed within 90 days of completing previous treatment (JCOG0901)
Scientific Title:Acronym Phase II study of Amrubicin in patients with Small-Cell Lung Cancer that is refractory or relapsed within 90 days of completing previous treatment (JCOG0901)
Region
Japan

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

Objectives
Narrative objectives1 To assess the efficacy and safety of amrubicin in patients with Small-Cell Lung Cancer that is refractory or relapsed within 90 days of completing previous treatment
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes response rate
Key secondary outcomes overall survival, progression-free survival, adverse events

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 Amrubicin (40 mg/m2/day) on days 1 through 3, every 3 weeks
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
74 years-old >=
Gender Male and Female
Key inclusion criteria 1) histologically or cytologically confirmed small-cell lung cancer
2) received one or two prior chemotherapy or chemoradiotherapy with platinum-based regimen
3) no prior treatment with amrubicin
4) underwent no operation of small-cell lung cancer
5) no prior thoracic radiotherapy within 4 weeks
6) refractory or relapsed within 90 days of completing previous treatment
7) pathologically confirmed local relapse of small-cell lung cancer, if it was difficult to distinguish from radiation pneumonitis
8) performance status of 0-1 on the Eastern Cooperative Oncology Group scale
9) age from 20 to 74 years
10) measurable disease
11) adequate organ function
12) written informed consent
Key exclusion criteria 1) active concomitant malignancy
2) active infection
3) fever
4) pregnancy or lactation
5) serious psychiatric illness
6) steroid treatment
7) massive pleural or pericardial effusion
8) symptomatic brain metastasis
9) interstitial pneumonia or severe pulmonary emphysema
10) ileus
11) myocardial infarction within 6 months or unstable angina
12) uncontrollable hypertension
13) uncontrollable diabetes mellitus
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuyuki Yamamoto
Organization Shizuoka Cancer Center
Division name Thoracic Oncology Division
Zip code
Address 1007, Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Haruyasu Murakami
Organization JCOG0901 Coordinating Office
Division name Shizuoka Cancer Center, Thoracic Oncology Division
Zip code
Address 1007, Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, JAPAN
TEL 055-989-5222
Homepage URL http://www.jcog.jp/
Email JCOG_sir@ml.jcog.jp

Sponsor
Institute Japan Clinical Oncology Group(JCOG)
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 国立病院機構道北病院(北海道)、
国立病院機構北海道がんセンター(北海道)、
KKR札幌医療センター(北海道)、
東北大学病院(宮城県)、
山形県立中央病院(山形県)、
茨城県立中央病院・茨城県地域がんセンター(茨城県)、
栃木県立がんセンター(栃木県)、
国立病院機構西群馬病院(群馬県)、
群馬県立がんセンター(群馬県)、
埼玉県立がんセンター(埼玉県)、
国立がんセンター東病院(千葉県)、
国立がんセンター中央病院(東京都)、
がん・感染症センター都立駒込病院(東京都)、
国立国際医療センター戸山病院(東京都)、
癌研究会有明病院(東京都)、
虎の門病院(東京都)、
神奈川県立がんセンター(神奈川県)、
横浜市立市民病院(神奈川県)、
新潟県立がんセンター新潟病院(新潟県)、
岐阜市民病院(岐阜県)、
静岡県立静岡がんセンター(静岡県)、
愛知県がんセンター中央病院(愛知県)、
愛知県がんセンター愛知病院(愛知県)、
大阪市立大学医学部附属病院(大阪府)、
近畿大学医学部(大阪府)、
大阪府立病院機構大阪府立成人病センター(大阪府)、
国立病院機構近畿中央胸部疾患センター(大阪府)、
国立病院機構刀根山病院(大阪府)、
大阪市立総合医療センター(大阪府)、
兵庫医科大学(兵庫県)、
兵庫県立がんセンター(兵庫県)、
岡山大学医学部・歯学部附属病院(岡山県)、
国立病院機構山口宇部医療センター(山口県)、
国立病院機構四国がんセンター(愛媛県)、
国立病院機構九州がんセンター(福岡県)、
九州大学病院(福岡県)、
熊本地域医療センター(熊本県)

Other administrative information
Date of disclosure of the study information
2009 Year 11 Month 13 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/24530204
Number of participants that the trial has enrolled
Results
See the datails via "URL releasing results" above.
Also the details can be seen in the JCOG website: 
http://www.jcog.jp/en/trials/index.html
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
2009 Year 09 Month 17 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2012 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2013 Year 07 Month 29 Day

Other
Other related information

Management information
Registered date
2009 Year 11 Month 13 Day
Last modified on
2014 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003129

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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