UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006620 |
|---|---|
| Receipt number | R000007830 |
| Scientific Title | Randomized phase II study of maintenance pemetrexed, bevacizumab, and pemetrexed+bevacizumab after induction chemotherapy with carboplatin+pemetrexed in advanced nonsquamous NSCLC. |
| Date of disclosure of the study information | 2012/01/01 |
| Last modified on | 2013/03/05 13:10:07 |
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Basic information
Public title
Randomized phase II study of maintenance pemetrexed, bevacizumab, and pemetrexed+bevacizumab after induction chemotherapy with carboplatin+pemetrexed in advanced nonsquamous NSCLC.
Acronym
Randomized phase II study of maintenance PEM, BEV, and PEM+BEV
Scientific Title
Randomized phase II study of maintenance pemetrexed, bevacizumab, and pemetrexed+bevacizumab after induction chemotherapy with carboplatin+pemetrexed in advanced nonsquamous NSCLC.
Scientific Title:Acronym
Randomized phase II study of maintenance PEM, BEV, and PEM+BEV
Region
| Japan |
Condition
Condition
nonsquamous NSCLC
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare maintenance chemotherapy between pemetrexed, bevacizumab, and pemetrexed and bevacizumab after induction chemotherapy with carboplatin+pemetrexed in nonsquamous NSCLC.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1-year progression-free survival rate from randomization.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
pemetrexed
Interventions/Control_2
bevacizumab
Interventions/Control_3
pemetrexed+bevacizumab
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
| Not applicable |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Induction chemotherapy
1.nonsquamous NSCLC
2.stage IIIB or IV
3.Age <75
4.ECOG PS 0-1
5.normal organ function
6.Written informed consent
Maintenance chemotherapy
1.non-PD after 4 cycles of induction chemotherapy
2.ECOG PS 0-1
3.normal organ function
Key exclusion criteria
Induction chemotherapy
1.severe comorbit disease
2.history of hemoptysis, coagulation disorder and thrombosis
3.tumor cavitation
4.invasion to the major vessel
5.myocardial infarction or brain infarction within 6 months
6.pregnant or lactating woman
7.brain metastasis with high risk of bleeding
8.interstitial pneumonia
9.effusion needed drainage
10.surgery within 4 weeks
11.radiation within 4 weeks
12.drainage within 1 week
13.double cancer
Maintenance chemotherapy
1)PD after induction chemotherapy
2)hemoptysis
3)bleeding tendency or thrombosis
4)ECOG PS 2-4
Target sample size
99
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Young Hak Kim |
Organization
Kyoto University
Division name
Respiratory Medicine
Zip code
Address
54 Shogoin-Kawaharacho, Sakyoku, Kyoto, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kyoto University
Division name
Respiratory Medicine
Zip code
Address
TEL
Homepage URL
ekim@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto Thoracic Oncology Research Group
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
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
| 2012 | Year | 01 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 09 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 27 | Day |
Last modified on
| 2013 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007830
