UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010733 |
|---|---|
| Receipt number | R000011272 |
| Scientific Title | Phase II study of Bevacizumab + Pemetrexed in elderly patients with advanced non-squamous non-small-cell lung cancer |
| Date of disclosure of the study information | 2013/05/16 |
| Last modified on | 2016/03/28 20:32:32 |
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Basic information
Public title
Phase II study of Bevacizumab + Pemetrexed in elderly patients with advanced non-squamous non-small-cell lung cancer
Acronym
Phase II study of BEV + PEM in elderly patients with advanced non-squamous non-small-cell lung cancer
Scientific Title
Phase II study of Bevacizumab + Pemetrexed in elderly patients with advanced non-squamous non-small-cell lung cancer
Scientific Title:Acronym
Phase II study of BEV + PEM in elderly patients with advanced non-squamous non-small-cell lung cancer
Region
| Japan |
Condition
Condition
Nonsquamous non-small-cell lung cancer
Classification by specialty
| Pneumology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of combination therapy with bevacizumab and pemetrexed for elderly patients with advanced non-squamous non-small-cell lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Progression free survival
Key secondary outcomes
Safety, Disease Control Rate (DCR), Response rate (RR), Overall Survival (OS), Quality of life (QOL), Exploration of biomarkers, Side effect prediction using the laboratory data
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
Bevacizumab 15mg/kg d1 q3w until PD
Pemetrexed 500mg/m2 d1 q3w until PD
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Histologically or cytologicalliy confirmed Stage3/4 non-squamous non-small cell lung cance
2) Age years or or older
3) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
4) With one or more measurable disease based on Response Evaluation Criteria in Solid Tumors
5) Adequate organ function
6)A life expectancy of more than 3 months.
7)All patients provided written informed consent before initiation of study-related procedures.
Key exclusion criteria
1) symptomatic brain metastasis
2) History of hemoptysis with 2.5mL or more
3) severe comorbidity (cardiovascular disease, pulmonary fibrosis/interstitial pneumonia, tendency to hemorrhages, uncontrolled hypertension or diabetes)
4) History of active double cancer within 5 years.
5) uncontrolled retention of fluid
6)receiving more than two anticoagulant drugs
7) active gastrointestinal bleeding or intraperitoneal inflammation
8) other inadequacy cases judged by attending physician
Target sample size
37
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoki Kimura |
Organization
Tosei General Hospital
Division name
Respiratory medicine and allergy
Zip code
Address
160 Nishioiwakecho, Seto, Aichi
TEL
0561-82-5101
lung@tosei.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eiji Kojima |
Organization
Komaki City Hospital
Division name
Division of Respiratory and Allergy Medicine
Zip code
Address
1-20 Jobushi, Komaki, Aichi
TEL
0568-76-4131
Homepage URL
lung@komakihp.gr.jp
Sponsor or person
Institute
Central Japan Lung Study Group
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
| 2013 | Year | 05 | Month | 16 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 03 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 30 | 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
| 2013 | Year | 05 | Month | 16 | Day |
Last modified on
| 2016 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011272
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
