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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000013122
Receipt No. 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

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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
Email 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
Email t.tani@z3.keio.jp

Sponsor
Institute Department of Pulmonary Medicine, School of Medicine, Keio University, Tokyo, Japan
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014068

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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