UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005143 |
|---|---|
| Receipt number | R000006066 |
| Scientific Title | A Phase 2 study of Carboplatin plus Pemetrexed plus Bevacizumab as first-line therapy for stage3B/4 non-squamous non-small-cell lung cancer |
| Date of disclosure of the study information | 2011/02/26 |
| Last modified on | 2014/09/02 13:49:26 |
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Basic information
Public title
A Phase 2 study of Carboplatin plus Pemetrexed plus Bevacizumab as first-line therapy for stage3B/4 non-squamous non-small-cell lung cancer
Acronym
A Phase 2 study of Carboplatin plus Pemetrexed plus Bevacizumab as first-line therapy for stage3B/4 non-squamous non-small-cell lung cancer
Scientific Title
A Phase 2 study of Carboplatin plus Pemetrexed plus Bevacizumab as first-line therapy for stage3B/4 non-squamous non-small-cell lung cancer
Scientific Title:Acronym
A Phase 2 study of Carboplatin plus Pemetrexed plus Bevacizumab as first-line therapy for stage3B/4 non-squamous non-small-cell lung cancer
Region
| Japan |
Condition
Condition
Lung Cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the efficacy and safety of Carboplatin plus Pemetrexed plus Bevacizumab as first-line therapy in patients with stage3B/4 nonsquamous non-small-cell lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
response rate
Key secondary outcomes
Progression-free survival(PFS)
Overall survival(OS)
Safety
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
Carboplatin and Pemetrexed and Bevacizumab on Day1,every 3 weeks,up to 6 cycles. Achieved disease control without unacceptable toxicity receive Pemetrexed and Bevacizumab on Day1 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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Histologically or cytologically proven non-squamous non small cell lung cancer
2)Patients with Stage3B/4 or postoperative recurrence NSCLC
3)Chemo-naïve patient
4)Age:20 years to less than 75 years
5)ECOG Performance status 0-1
6)Patients who has measurable by RECIST(ver1.1)criteria
7)Patients who has the following periods
i.Palliative radiotherapy:1weeks
ii.Operation:4weeks
iii.Thoracic cavity drainage:2weeks
vi.Biopsy with incision,poet custody,and treatment to injury:2weeks
v.Aspiration biopsy cytology:1weeks
8)Adequate organ function
9)Life expectancy more than 3 months
10)Signed written informed consent
Key exclusion criteria
1)Uncontrolled infection or Serious medical complications
2)Uncontrolled pleural effusion or ascites
3)Brain metastases
4)Serious disease condition
5)Uncontrolled diabetes mellitus
6)Therapeutic anticoagulopathy
7)Uncontrolled hyper tension
8)Current or previous history of GI
perforation
9)interstitial lung disease or fibroid lung
10)history of drug-induced interstitial lung diseas
11)Current or previous history of hemoptysis
12)history of hemoptysis
13)Scheduling operation for examination time
14)Treatment history of carboplatin,pemetrexed,bevacizumab
15)Drug allergens
16)Multiple primary cancer
17)Serious psychiatric illness or psychological symptom
18)Women who are pregnant, lactating or with childbearing potential.
19)Ineligible based on decision of an investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiki Ishii |
Organization
Dokkyo Medical University School of Medicine
Division name
Pulmonary Medicine and Clinical Immunology
Zip code
Address
880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi, 321-0293 JAPAN
TEL
0282-87-2151
ishiiysk@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiki Ishii |
Organization
Dokkyo Medical University School of Medicine
Division name
Pulmonary Medicine and Clinical Immunology
Zip code
Address
880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi, 321-0293 JAPAN
TEL
0282-87-2151
Homepage URL
ishiiysk@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Southern Tohoku General Hospital
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
獨協医科大学病院（栃木県）
総合南東北病院（福島県）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 26 | 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
| 2009 | Year | 01 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2009 | 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 | 02 | Month | 25 | Day |
Last modified on
| 2014 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006066
