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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000006874
Receipt No. R000008123
Scientific Title A phase II study of Conbination therapy of Cisplatin/Pemetrexed/Bavacizumab in previously untreated patients with StageIIIB/IV or recurrent disease nonsquamous non-small cell lung cancer
Date of disclosure of the study information 2011/12/12
Last modified on 2012/11/21

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Basic information
Public title A phase II study of Conbination therapy of Cisplatin/Pemetrexed/Bavacizumab in previously untreated patients with StageIIIB/IV or recurrent disease nonsquamous non-small cell lung cancer
Acronym A phase II study of Conbination therapy of Cisplatin/Pemetrexed/Bavacizumab in previously untreated patients with StageIIIB/IV or recurrent disease nonsquamous non-small cell lung cancer
Scientific Title A phase II study of Conbination therapy of Cisplatin/Pemetrexed/Bavacizumab in previously untreated patients with StageIIIB/IV or recurrent disease nonsquamous non-small cell lung cancer
Scientific Title:Acronym A phase II study of Conbination therapy of Cisplatin/Pemetrexed/Bavacizumab in previously untreated patients with StageIIIB/IV or recurrent disease nonsquamous non-small cell lung cancer
Region
Japan

Condition
Condition non-small cell lung cancer
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy and safety of Cisplatin plus Pemetrexed and Bavacizumab in previously treated patients with StageIIIB/IV or recurrent disease non- squamous non-small cell lung cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Two years overall survival rate
Key secondary outcomes Progression-free survival, Overall survival, Time to Treatment Failure, Response rate, Disease control rate, Adverse events, Response rate of each EGFR status, Biomarkers

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 Patients were given Cisplatin (75mg/m2, div), Pemetrexed (500mg/m2, div) and Bevacizumab (15mg/kg, div) on day 1, every 3 weeks, up to 6 courses more than 4 courses. Patients without unacceptable toxity, then continuously are treated with Pemetrexed (500mg/m2) and Bevacizumab (15mg/kg, div) on day 1, every 3 weeks, 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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)histologically or cytologically confirmed non-squamous non-small-cell lung cancer
2)stage IIIB/IV or postoperative recurrence patients
3)chemotheraoy naive patients
4)Performance Status(ECOG) 0-1
5)Patient who has at least one or more measurable lesion by RECIST
6)Patients aged 20 years or older
7)Sufficient function of main organ and normal hematopoietic function, normal liver function and normal renal function filled the following criteria
*Leukocyte counts >= 3,000/mm3
*Neutrophil counts >= 1,500/mm3
*Platelets >= 100,000/mm3
*Hemoglobin concentration >= 9.0 g/dL
*AST and ALT, x 2.5 of upper limit of normal (ULN) or less.
*Total bilirubin <=1.5mg/dL.
*Serum creatinin, x 1.5 of ULN or less.
*Electrocardiogram Nomal
*SpO2 >=90% or SaPO2 >=65mmHg
*Protein urea >= 1+
8)Patients who are considered to survive for more than 3 months.
9)interval:
(1)Radiation
*More than 2 weeks after the last irradiation to other organs.
(2)Operation (including pleurodesis)
*More than 4 weeks after the operation without Lobectomy (including exploratory surgery)
*More than 2 weeks after the last operation (including pleurodesis)
10)Patients providing written informed consent
Key exclusion criteria 1)Patients with untreated Brain metastases
2)Patients with current or previous history of hemoptysis (2.5mL or more)
3)Patients with uncontrolled hyper tension
4)Patients with uncontrolled infection
5)Patients with active lung disease such as interstitial pneumonia, pneumoconiosis, active radiation pneumonitis, pulmonary fibrosis or drug-induced pneumonitis
6)Patients with uncontrollable complications
7)Patients with massive pleural or pericardial effusion,or ascites
8)Patients with active concomitant malignancy
9)Patients with previous histories of drug allergy
10)Patients with uncontrollable gastrointestinal ulceration
11)Patients with current or previous (within one year) history of gastrointestinal perforation
12)Patients with therapeutic anticoagulopathy (including Aspirin over 325mg/day)
13)Pregnancy or lactation
14)Inappropriate patients for this study judged by the physicians
Target sample size 37

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Suzuki
Organization Fukushima medical University
Division name Department of Regenerative Surgery
Zip code
Address 1 Hikariga-oka, Fukushima City, Fukushima Prefecture 960-1295 JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Suzuki
Organization Fukushima medical University
Division name Department of Regenerative Surgery
Zip code
Address 1 Hikariga-oka, Fukushima City, Fukushima Prefecture 960-1295 JAPAN
TEL 024-547-1111
Homepage URL
Email

Sponsor
Institute Fukushima medical University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Shirakawa Kosei General Hosptal
Takeda General Hospital
Fukushima Red Cross Hospital
Fukushima accident Hospital
Southern TOHOKU General Hospital
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 福島県立医科大学附属病院 (福島県)
白河厚生総合病院 (福島県)
竹田綜合病院 (福島県)
福島赤十字病院 (福島県)
福島労災病院 (福島県)
総合南東北病院 (福島県)

Other administrative information
Date of disclosure of the study information
2011 Year 12 Month 12 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
2011 Year 12 Month 09 Day
Date of IRB
Anticipated trial start date
2012 Year 01 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
2011 Year 12 Month 12 Day
Last modified on
2012 Year 11 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008123

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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