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Recruitment status Terminated
Unique ID issued by UMIN UMIN000007475
Receipt No. R000008808
Scientific Title A randomized phase II study of Erlotinib with or without Bevacizumab in NSCLC patients previouly treated with platinum-based chemotherapy containing bevacizumab. North Japan Lung Cancer Study Group Trial 1201
Date of disclosure of the study information 2012/03/09
Last modified on 2014/09/09

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Basic information
Public title A randomized phase II study of Erlotinib with or without Bevacizumab in NSCLC patients previouly treated with platinum-based chemotherapy containing bevacizumab.
North Japan Lung Cancer Study Group Trial 1201
Acronym Randomized phase II study of 2nd line Erlotinib with or without Bevacizumab (NJLCG1201)
Scientific Title A randomized phase II study of Erlotinib with or without Bevacizumab in NSCLC patients previouly treated with platinum-based chemotherapy containing bevacizumab.
North Japan Lung Cancer Study Group Trial 1201
Scientific Title:Acronym Randomized phase II study of 2nd line Erlotinib with or without Bevacizumab (NJLCG1201)
Region
Japan

Condition
Condition non-squamous non-small cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate and compare the efficacy and safety of combination of bevacizumab and erlotinib versus erlotinib monothearpy in NSCLC patients who were previously treated with bevacizumab containing rejimen.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Progression Free Survival at 3 months after randomized
Key secondary outcomes Response Rate, Disease Control Rate, Progression Free Survival, Overall Survival, Safety

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 not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Erlotinib
Interventions/Control_2 Erlotinib + Bevacizumab
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)stage IIIB/IV or recurrence and histologically or cytologically confirmed non-squamous non-small lung cancer
2)history of 2 courses or more bevacizumab plus platinum doublet
3)known no active EGFR gene mutation
4)20 years or older
5)PS:0-2 (ECOG)
6)at least one measurable leision (RECIST)
7)patients who has the following periods
*the last prior chemotherapy:3weeks
*palliative radiotherapy(ex thorax):2weeks
*operation:4 weeks
*chest drainage:1weeks
*biopsy with incision, port custody,and treatment to injury:2weeks
8)adequate bone marrow,liver,and renal functions
9)a life expectancy of 3 months or more
10)written informed consent
Key exclusion criteria 1)Pulmonary disorder(idiopathic pulmonary fibrosis,interstitial lung disease, pneumoconiosis, active radiation pneumonia, etc.).
2)known active EGFR gene mutation
3)history of erlotinib or gefitinib treatment
4)inable of oral drug administration
5)current or previous histoty of hemoptysis(2.5ml)due to NSCLC
6)Risk of hemoptysis patients after thoracic radiation therapy is expected
7)With great vessel invasion
8)1cm or longer cavity in tumor
9)current or previous (within the last 1 year)history of GI perforation
10)history of myocardial infarction and cerebral infarction
11)planned surgery within study term
12)uncontrolled heypertension
13)symptomatic brain metastasis
14)history of drug allergy
15)massive,pleural effusion or ascites
16)uncontrolled infection or serious medical complications
17)active concomitant malignancy
18)mental disorder
19)pregnant or or lactating women or those who declined contraception
20)those judged not suitable by the attending physician
Target sample size 64

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shunichi Sugawara
Organization Sendai Kousei Hospital
Division name Department of Respiratory Medicine
Zip code
Address 4-15 Hirosemachi, Aobaku, Sendai, Miyagi 980-0873
TEL 022-222-6181
Email swara357@cat-v.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shunichi Sugawara
Organization Sendai Kousei Hospital
Division name Department of Respiratory Medicine
Zip code
Address 4-15 Hirosemachi, Aobaku, Sendai, Miyagi 980-0873
TEL 022-222-6181
Homepage URL
Email swara357@cat-v.ne.jp

Sponsor
Institute North Japan Lung Cancer Study Group
Institute
Department

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
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NJLCG1201
Org. issuing International ID_1 North Japan Lung Cancer Study Group
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 03 Month 09 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
2012 Year 02 Month 16 Day
Date of IRB
Anticipated trial start date
2012 Year 03 Month 01 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
2012 Year 03 Month 09 Day
Last modified on
2014 Year 09 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008808

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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