UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008764 |
|---|---|
| Receipt number | R000010209 |
| Scientific Title | A phase II trial of pemetrexed/bevacizumab in the first-line treatment of elderly patients with advanced non-small cell lung cancer. |
| Date of disclosure of the study information | 2012/08/24 |
| Last modified on | 2014/08/24 09:04:50 |
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Basic information
Public title
A phase II trial of pemetrexed/bevacizumab in the first-line treatment of elderly patients with advanced non-small cell lung cancer.
Acronym
A phase II trial of pemetrexed/bevacizumab in elderly patients with advanced NSCLC.
Scientific Title
A phase II trial of pemetrexed/bevacizumab in the first-line treatment of elderly patients with advanced non-small cell lung cancer.
Scientific Title:Acronym
A phase II trial of pemetrexed/bevacizumab in elderly patients with advanced NSCLC.
Region
| Japan |
Condition
Condition
elderly patients with stage IIIB/IV non-small cell lung cancer except for squamous cell carcinoma
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of pemetrexed/bevacizumab in elderly patients with advanced non-small cell lung cancer except for squamous cell carcinoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
response rate
Key secondary outcomes
disease control rate, progression free survival, overall survival, safety, QOL
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
Pemetrexed(500mg/m2) and bevacizumab(15mg/kg) will be administered triweekly until disease progression.
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 confirmed non-small cell lung cancer except for squamous cell carcinoma
2) clinical stage IIIB/IV or relapsed case
3) chemotherapy naive
4) PS (ECOG) 0-1
5) with mesurable lesions
6) more than 75 years old
7) with sufficient bone marrow, liver and kidney function
8) with asymptomatic and/or well controled brain metastases
9) estimated survival is more than 3 months
10) with written informed consent
Key exclusion criteria
1) history of hemoptysis (more than 2.5mL)
2) with pulmonary cavitary lesions
3) with invasion to the aorta and/or pulmonary arteries
4) tumor outcrop in main bronchus
5) history of radical thoracic radiotherapy
6) patients treated by anti-coagulation therapy complicated with brain metastasis
7) with severe infection
8) with massive pleural effusion, ascites or pericardial effusion
9) overlapped with other malignancies
10) with severe peptic ulcer
11) history of perforation in digestive tract
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiko Nishioka |
Organization
The University of Tokushima Graduate School, Institute of Health Biosciences
Division name
Department of Respiratory Medicine and Rheumatology
Zip code
Address
3-8-15, Kuramoto-cho, Tokushima
TEL
088-633-7127
yasuhiko@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaki Hanibuchi |
Organization
The University of Tokushima Graduate School, Institute of Health Biosciences
Division name
Department of Respiratory Medicine and Rheumatology
Zip code
Address
3-8-15, Kuramoto-cho, Tokushima
TEL
088-633-7127
Homepage URL
mhoney@tokushima-u.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine and Rheumatology, Institute of Health Biosciences, The University of Tokushima Graduate School
Institute
Department
Personal name
Funding Source
Organization
Department of Respiratory Medicine and Rheumatology, Institute of Health Biosciences, The University of Tokushima Graduate School
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
徳島大学病院(徳島県)、徳島県立中央病院(徳島県)、徳島市民病院(徳島県)、高松赤十字病院(香川県)、国立病院機構高知病院(高知県)、高知医療センター(高知県)、高知赤十字病院(高知県)、松山赤十字病院(愛媛県)、国立病院機構大阪医療センター(大阪府)、聖路加国際病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 24 | 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
Preinitiation
Date of protocol fixation
| 2012 | Year | 08 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 24 | Day |
Last modified on
| 2014 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010209
