UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003653 |
|---|---|
| Receipt number | R000004426 |
| Scientific Title | Phase II study of S-1 plus amrubicin as the 2nd-line treatment for non-small cell lung cancer without EGFR mutation |
| Date of disclosure of the study information | 2010/05/25 |
| Last modified on | 2017/07/11 09:31:53 |
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Basic information
Public title
Phase II study of S-1 plus amrubicin as the 2nd-line treatment for non-small cell lung cancer without EGFR mutation
Acronym
Phase II study of S-1 plus amrubicin as the 2nd-line treatment for non-small cell lung cancer without EGFR mutation
Scientific Title
Phase II study of S-1 plus amrubicin as the 2nd-line treatment for non-small cell lung cancer without EGFR mutation
Scientific Title:Acronym
Phase II study of S-1 plus amrubicin as the 2nd-line treatment for non-small cell lung cancer without EGFR mutation
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of 2nd-line chemotherapy with amrubicin and TS-1 for non-small cell lung cancer without EGFR mutation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
over all survival, progression free survival and frequency of adverse events
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 (day1-3) + TS-1 (day1-14)
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)histologically or cytologically confirmed non-small cell lung cancer
2)unresectable disease
3)EGFR mutation negative or unknown
4)Age: 20-69 years old
5)Life expectancy more than 12weeks
6)ECOG Perfomance status 0-1
7)Previous 1- regimen chemotherapy consisting of platinum
8)Interval of more than 28 days from the last chemotherapy or radiotherapy
9)preserved organ's function
WBC>=4,000/mm3
Hemoglobin>= 10.0g/dl
Platelet count>=100,000/mm3
Total serum bilirubin <=1.5 mg/dl
GOT/GPT <90 IU/l
Serum creatinine <=1.5mg/dl
10)Acquisition of written informed consent
Key exclusion criteria
1)patients previously treated with amrubicin and 5-FU derivative drugs
2)pleural effusion(eligible for difficult puncture case or cytologically negative and clinically ignorable case)
3)evident pericardial effusion
4)serious complications below
uncontrollable angina pectoris, myocardial infarction within 3 months or heart failure
uncontrollable diabetes
uncontrollable hypertension
severe infection
5)pulmonary fibrosis or interstitial pneumonitis evident
6)HB and HC virus carrier
7)now pregnant or lactation
8)difficult to perform or continue of this study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumihiro Oshita |
Organization
Kanagawa Cancer Center
Division name
Department of Thoracic Oncology
Zip code
Address
1-1-2, Nakao, Asahi-ku, Yokohama, Japan
TEL
045-391-5761
foshita@kcch.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shuji Murakami |
Organization
Kanagawa Cancer Center
Division name
Department of Thoracic Oncology
Zip code
Address
1-1-2 nakao asahi-ku yokohama-city, kanagawa
TEL
045-391-5761
Homepage URL
murakamis@kcch.jp
Sponsor or person
Institute
Kanagawa Cancer Center
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 05 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2010 | Year | 04 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | Month | 24 | Day |
Last modified on
| 2017 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004426
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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