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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003855
Receipt No. R000004625
Scientific Title Phase II study of cisplatin, pemetrexed plus bevacizumab for EGFR mutation negative or unknown stage III/IV non-small-cell lung cancer (non-squamous cell lung cancer)
Date of disclosure of the study information 2010/07/01
Last modified on 2013/03/13

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Basic information
Public title Phase II study of cisplatin, pemetrexed plus bevacizumab for EGFR mutation negative or unknown stage III/IV non-small-cell lung cancer (non-squamous cell lung cancer)
Acronym Phase II study of CDDP/PEM/BEV for EGFR mutation negative stage III/IV non-small-cell lung cancer)
Scientific Title Phase II study of cisplatin, pemetrexed plus bevacizumab for EGFR mutation negative or unknown stage III/IV non-small-cell lung cancer (non-squamous cell lung cancer)
Scientific Title:Acronym Phase II study of CDDP/PEM/BEV for EGFR mutation negative stage III/IV non-small-cell lung cancer)
Region
Japan

Condition
Condition EGFR mutation negative or unknown stage III/IV non-small-cell lung cancer (non-squamous cell carcinoma)
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Efficacy and safty of cisplatin, pemetrexed plus bevacizumab for EGFR mutation negative or unknown unresectable stage III/IV non-small-cell lung cancer (non-squamous cell carcinoma)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes response rate
Key secondary outcomes overall survival, progression disease free survival, adverse event rate

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 cisplatin 75mg/m2 (day1), pemetrexed 500mg/m2 (day1) and bevacizumab 15mg/kg (day1), every 3-4 weeks, total 3-6 courses. After that, bevacizumab 15mg/kg (day1), every 3-4 weeks until PD.
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
70 years-old >=
Gender Male and Female
Key inclusion criteria 1)Non-small-cell (Non-squamous cell) lung cancer
2)Unresectable stage III/IV and postoperative relapsed cases
3)EGFR mutation negative or unknown
4)Chemotherapy naive
5)Target lesion is measurable
6)More than 20 years old, less than 75 years old
7)Expected survival is more than 12 weeks
8)ECOG Perfomance Status 0-1
9)Adequate hematologic, hepatic, and renal functions
10)More than 2 weeks rest period after palliative radiation or control of pleural effusion
11)Written informed consent
Key exclusion criteria 1)Massive pleural effusion
2)Massive pericardial effusion
3)Double cancer
4)Severe complications; myocardial infarction, unstable angina, heart failure, uncontrolled hypertension, and unconrolled diabetis mellitus, uncontrolled infection, uncontrolled mental disease, SVC syndrome
5)Hemoptysis(more than 2.5ml), continuous or treatment-required bloody sputum
6)Invasion to large vessels, cavity in tumor
7)Brain metastsis
8)Under anti-coagulation therapy
9)Bleeding
10)Nephrosis
11)Uncured wound
12)Digestive tract ulcer, diverticulosis
13)Bone marrow suppression
14)Lung fibrosis
15)Pregnancy
16)Other inappropriate cases

Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kouzo Yamada
Organization Kanagawa Cancer Center
Division name Thoracic Oncology
Zip code
Address Nakao 1-1-2, Asahiku, Yokohama City
TEL 045-391-5761
Email

Public contact
Name of contact person
1st name
Middle name
Last name Haruhiro Saito
Organization Kanagawa Cancer Center
Division name Thoracic Oncology
Zip code
Address Nakao 1-1-2, Asahiku, Yokohama City
TEL 045-391-5761
Homepage URL
Email saito-h@kcch.jp

Sponsor
Institute Departmnent of Thoracic Oncology
Kanagawa Cancer Center
Institute
Department

Funding Source
Organization Departmnent of Thoracic Oncology
Kanagawa Cancer Center
Organization
Division
Category of Funding Organization Local Government
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 NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 神奈川県立がんセンター(神奈川県)

Other administrative information
Date of disclosure of the study information
2010 Year 07 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 Completed
Date of protocol fixation
2010 Year 06 Month 17 Day
Date of IRB
Anticipated trial start date
2010 Year 07 Month 01 Day
Last follow-up date
2015 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 07 Month 01 Day
Last modified on
2013 Year 03 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004625

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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