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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009129
Receipt No. R000010702
Scientific Title A phase II study of Pemetrexed combination with Bevacizumab in the first-line treatment of elderly patients with advanced Non-squamous Non-small cell lung cancer
Date of disclosure of the study information 2012/11/01
Last modified on 2016/10/20

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Basic information
Public title A phase II study of Pemetrexed combination with Bevacizumab in the first-line treatment
of elderly patients with advanced Non-squamous Non-small cell lung cancer
Acronym A phase II study of Pemetrexed combination with Bevacizumab in the first-line treatment
of elderly patients with advanced Non-squamous Non-small cell lung cancer
Scientific Title A phase II study of Pemetrexed combination with Bevacizumab in the first-line treatment
of elderly patients with advanced Non-squamous Non-small cell lung cancer
Scientific Title:Acronym A phase II study of Pemetrexed combination with Bevacizumab in the first-line treatment
of elderly patients with advanced Non-squamous Non-small cell lung cancer
Region
Japan

Condition
Condition elderly patients with stage IIIB/IV non-small cell lung cancer except for squamous cell carcinoma
Classification by specialty
Hematology and clinical oncology
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-squamous Non-smallcell lung cancer
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,
evaluavte effectiveness by tumor maker(CYFRA)

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) chemotherapy naive

3) clinical stage IIIB/IV or relapsed case

4) with measurable lesions

5) written informed consent after the explanation of the content of the examination

6) more than 75-years old

7) PS (ECOG) 0-2

8) estimated survival is more than 3 months

9) Adequate organ functions
Neutrophil: => 1500 /mm3
Platelet: => 100,000 /mm3
Hemoglobin concentration: => 9.0 g/dl
Total bilirubin: <= 1.5 mg/dl
AST or ALT: <= 100IU/l
Cr: <= 1.2 mg/dl
proteinuria: <= 1+
Key exclusion criteria 1) transfusion or G-CSF within 2weeks prior to enrollment

2) history of severe drug allergy

3) history of active double cancer within 5 years

4) history of active severe infections

5) severe cardiac disease

6) history of thromboembolism or severe pulmonary disease

7) history of GI bleeding, ileus, GI ulceration

8) history of hemoptysis (more than 2.5mL)

9) massive pleural or pericardial effusion, ascites

10) active brain metastases

11) history of mental disorder, central nervous system damage, cerebrovascular disease

12) Uncontrollable hypertension or diabetes mellitus

13)Uncontrollable diarrhea

14)Wound of unrecovery

15)bleeding diathesis or receiving anticoagulant drug(except Aspirin under 324mg/day)

16)Evaluated to be ineligible by a physician for other reasons


Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keisuke Aoe
Organization Yamaguchi-Ube Medical Center
Division name Department of Medical Oncology
Zip code
Address 685, Higasikiwa Ube, Yamaguchi
TEL 0836-58-2300
Email aoe@yamaguchi-hosp.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keisuke Aoe
Organization Yamaguchi-Ube Medical Center
Division name Department of Medical Oncology
Zip code
Address 685 Higashikiwa, Ube, Yamaguchi
TEL 0836-58-2300
Homepage URL
Email maeda@yamaguchi-hosp.jp

Sponsor
Institute Yamaguchi Thoracic Oncology Group (YTOG)
Institute
Department

Funding Source
Organization No
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
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 山口大学医学部附属病院、徳山中央病院、長門総合病院、済生会下関総合病院、山口県立総合医療センター、下関市立市民病院、関門医療センター、岩国医療センター、済生会山口総合病院、山口宇部医療センター

Other administrative information
Date of disclosure of the study information
2012 Year 11 Month 01 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 Open public recruiting
Date of protocol fixation
2012 Year 09 Month 25 Day
Date of IRB
Anticipated trial start date
2012 Year 10 Month 01 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 10 Month 16 Day
Last modified on
2016 Year 10 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010702

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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