UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001246 |
|---|---|
| Receipt number | R000001518 |
| Scientific Title | Randomized phase II trial comparing amrubicine/irinotecan with cisplatin/irinotecan in patients with extensive-stage small-cell lung cancer: (JMTO LC 08-01) |
| Date of disclosure of the study information | 2008/07/15 |
| Last modified on | 2019/03/22 14:59:48 |
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Basic information
Public title
Randomized phase II trial comparing amrubicine/irinotecan with cisplatin/irinotecan in patients with extensive-stage small-cell lung cancer: (JMTO LC 08-01)
Acronym
Randomized phase II trial comparing amrubicine/irinotecan with cisplatin/irinotecan in patients with ED-SCLC: (JMTO LC 08-01)
Scientific Title
Randomized phase II trial comparing amrubicine/irinotecan with cisplatin/irinotecan in patients with extensive-stage small-cell lung cancer: (JMTO LC 08-01)
Scientific Title:Acronym
Randomized phase II trial comparing amrubicine/irinotecan with cisplatin/irinotecan in patients with ED-SCLC: (JMTO LC 08-01)
Region
| Japan |
Condition
Condition
extensive-disease small-cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of amrubicine and irinotecan combination therapy for chemonaive patients with ED-SCLC
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
overall survival (1-year survival rate)
Key secondary outcomes
progression free survival
response rate
safety (incidence of an adverse event)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
A:Patients receive amrubicine on day 1 and irinotecan on days 1 and 8. Courses repeat every 3 weeks.
Interventions/Control_2
B:Patients receive cisplatin on day 1 and irinotecan on days 1, 8, and 15. Courses repeat every 4 weeks.
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) histologically or cytologically proven small-cell lung cancer
2) extensive-stage small-cell lung cancer or limited-stage small-cell lung cancer with malignant pleural or pericardial effusion
3) no prior chemotherapy
4) performance status of 0 to 2
5) predicted life expectancy of 3 months
6) patients who has received palliative radiotherapy for brain or bone metastases can be included
7) adequate organ functions
8) measurable or unmeasurable disease
9) age 20 years or older
10) written informed consent
Key exclusion criteria
1)uncontrollable pleural, pericardial effusion or ascites
2)uncontrolled heart disease
3)uncontrolled diabetes mellitus
4)active infection
5)radiotherapy including pulmonary field
6)interstitial pneumonia/active lung fibrosis on chest x-ray
7)patients who has been taking steroid or immunosuppressant for any other disease
8)watery diarrhea, intestinal paralysis or obstruction
9)history of severe drug allergy
10)active concomitant malignancy
11)pregnant or lactating woman
12)patients whose participation in the trial is judged to be inappropriate by the attending doctor
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshige Yoshioka |
Organization
Kurashiki Central Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
1-1-1, Miwa, Kurashiki, Okayama 710-8602, Japan
TEL
086-422-0210
hirotin@kchnet.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Saori Kato |
Organization
The Japan-multinational Trial Organization
Division name
The Japan-multinational Trial Organization datacenter
Zip code
Address
460-0002 P-A Bldg. 3F,2-14-10 Marunouchi,Naka-ku, Nagoya,Aichi, Japan
TEL
052-218-3301
Homepage URL
jmto-adm@jmto.org
Sponsor or person
Institute
The Japan-multinational Trial Organization
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
倉敷中央病院（岡山県）、先端医療センター（兵庫県）、神戸市立医療センター中央市民病院（兵庫県）、京都大学医学部附属病院（京都府）、近畿中央胸部疾患センター（大阪府）、大阪警察病院（大阪府）、京都桂病院（京都府）、藤沢市民病院（神奈川県）、広島市民病院（広島県）、滋賀県立成人病センター（滋賀県）、一宮西病院（愛知県）、大手前病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 07 | Month | 15 | 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
| 2008 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2008 | Year | 05 | Month | 16 | Day |
Anticipated trial start date
| 2008 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | 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
| 2008 | Year | 07 | Month | 13 | Day |
Last modified on
| 2019 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001518
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