UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003855 |
|---|---|
| Receipt number | 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 14:53:22 |
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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
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
saito-h@kcch.jp
Sponsor or person
Institute
Departmnent of Thoracic Oncology
Kanagawa Cancer Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004625
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