UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013122 |
|---|---|
| Receipt number | R000014068 |
| Scientific Title | A randomized phase II study of the efficacy and safety of combination of Bevacizumab/Pemetrexed versus Pemetrexed maintenance therapy in First-Line treatment of elderly patients with advanced or recurrent post-operative non-squamous and non-small cell lung cancer who received Bevacizumab / Pemetrexed induction therapy. |
| Date of disclosure of the study information | 2014/02/10 |
| Last modified on | 2015/05/28 16:54:47 |
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Basic information
Public title
A randomized phase II study of the efficacy and safety of combination of Bevacizumab/Pemetrexed versus Pemetrexed maintenance therapy in First-Line treatment of elderly patients with advanced or recurrent post-operative non-squamous and non-small cell lung cancer who received Bevacizumab / Pemetrexed induction therapy.
Acronym
A randomized phase II study of Bevacizumab/Pemetrexed versus Pemetrexed maintenance therapy in elderly NSCLC who received Bevacizumab / Pemetrexed induction therapy.
Scientific Title
A randomized phase II study of the efficacy and safety of combination of Bevacizumab/Pemetrexed versus Pemetrexed maintenance therapy in First-Line treatment of elderly patients with advanced or recurrent post-operative non-squamous and non-small cell lung cancer who received Bevacizumab / Pemetrexed induction therapy.
Scientific Title:Acronym
A randomized phase II study of Bevacizumab/Pemetrexed versus Pemetrexed maintenance therapy in elderly NSCLC who received Bevacizumab / Pemetrexed induction therapy.
Region
| Japan |
Condition
Condition
non-squamous non-small cell lung cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluate efficacy and safety of of combination of Bevacizumab/Pemetrexed versus Pemetrexed maintenance therapy in First-Line treatment of elderly patients with advanced or recurrent post-operative non-squamous and non-small cell lung cancer who received Bevacizumab / Pemetrexed induction therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Progression-free survival
Key secondary outcomes
Response rate, Disease control rate, Overall survival, Adverse event rate
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 a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Pemetrexed
Bevacizumab
Interventions/Control_2
Pemetrexed
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 cytologically proven non-squamous non-small cell lung cancer
2)stageIII/IV or recurrent post-operative non-squamous and non-small cell lung cancer
3) No prior use of chemotherapy
4)PS:0-1 (ECOG)
5)at least one measurable leision (RECIST)
6)Patients aged 75 or over
7)adequate bone marrow,liver,and renal functions
8)patients who has the following periods
*radiotherapy:2weeks
*operation(surgery with lobectomy):8 weeks
*operation(surgery without lobectomy):4weeks
*pleurodesis,chest drainage:2weeks
9)written informed consent
Key exclusion criteria
1)Patients with symptomatic Brain metastasis
2)History of hemoptysis
3)History of thoracic radiotherapy
4)active infection
5)fever
6)severe complication
7)massive pleural effusion or ascites
8)active concomitant malignancy
9)history of severe drug allergy
10)uncontrolled peptic ulcer
11)Current or previous history of GI perforation
12)Patients with therapeutic anticoagulopathy
13)those judged not suitable by the attending physician
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenzo Soejima |
Organization
School of Medicine, Keio University, Tokyo, Japan
Division name
Department of Pulmonary Medicine
Zip code
Address
shinamomachi 35, shinjyuku-ku, Tokyo
TEL
0333531211
ksoejima@cpnet.med.keio.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuo Tani |
Organization
School of Medicine, Keio University, Tokyo, Japan
Division name
Department of Pulmonary Medicine
Zip code
Address
shinamomachi 35, shinjyuku-ku, Tokyo
TEL
0333531211
Homepage URL
t.tani@z3.keio.jp
Sponsor or person
Institute
Department of Pulmonary Medicine, School of Medicine, Keio University, Tokyo, Japan
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
none
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
慶應義塾大学病院(東京都)
永寿総合病院(東京都）
川崎市立川崎病院（神奈川県）
川崎市立井田病院（神奈川県）
国際医療福祉大学塩谷病院（栃木県）
国立病院機構東京医療センター（東京都）
国家公務員共済連合会立川病院（東京都）
済生会宇都宮病院（栃木県）
さいたま市立病院（埼玉県）
埼玉社会保険病院（埼玉県）
佐野厚生総合病院（栃木県）
東京歯科大学市川総合病院（千葉県）
東京都済生会中央病院（東京都）
日本鋼管病院（神奈川県）
日野市立病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 02 | Month | 10 | 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 | 06 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 10 | 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
| 2014 | Year | 02 | Month | 10 | Day |
Last modified on
| 2015 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014068
