UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003387 |
|---|---|
| Receipt number | R000004112 |
| Scientific Title | Phase II Study of Carboplatin+Pemetrexed+Bevacizumab in chemo-naive patients with stage IIIB and IV non-squamous non-small cell lung cancer(NSCLC). |
| Date of disclosure of the study information | 2010/04/01 |
| Last modified on | 2017/08/21 08:24:03 |
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Basic information
Public title
Phase II Study of Carboplatin+Pemetrexed+Bevacizumab in chemo-naive patients with stage IIIB and IV non-squamous non-small cell lung cancer(NSCLC).
Acronym
Phase II Study of Carboplatin+Pemetrexed+Bevacizumab in chemo-naive patients with stage IIIB and IV non-squamous non-small cell lung cancer(NSCLC).
Scientific Title
Phase II Study of Carboplatin+Pemetrexed+Bevacizumab in chemo-naive patients with stage IIIB and IV non-squamous non-small cell lung cancer(NSCLC).
Scientific Title:Acronym
Phase II Study of Carboplatin+Pemetrexed+Bevacizumab in chemo-naive patients with stage IIIB and IV non-squamous non-small cell lung cancer(NSCLC).
Region
| Japan |
Condition
Condition
non-squamous non-small cell lung cancer
Classification by specialty
| Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of Carboplatin+Pemetrexed+Bevacizumab in chemo-naive stage IIIB/IV non-squamous non-small cell lung cancer(NSCLC).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Response Rate
Key secondary outcomes
Progression Free Survival
Overall Survival
Time to Response
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
Patients receive CBDCA(AUC6,i.v.), Pemetrexed(500mg/m2,i.v.) and Bevacizumab(15mg/kg,i.v.) on Day1, every three weeks, up to six cycles.Patients who achieved disease control(response or stable disease) without unacceptable toxicity receive Pemetrexed(500mg/m2,i.v.) and Bevacizumab(15mg/kg,i.v.) on Day1, every three weeks, untill disease porogression.
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 confirmed non-squamous non-small cell lung cancer(NSCLC)
2)Stage IIIB/IV(UICC-7) or postoperative recurrence NSCLC
3)cheno-naive patient(except oral 5-FU)
4)Age:20 years to less than 75 years.
5)ECOG performance status of 0 or 1
6)Measurable by RECST(ver 1.1) criteria.
7)Patient who has the following periods.
palliative radiotherapy(ex thorax):2 weeks
operation:4 weeks
chest drainage:2 weeks
Biopsy with incision, port custody, and treatment to injury:2 weeks
Aspiration biopsy cytology:1 week
8)adequate bone marrow, liver, and renal functions
neutro > 1,500/mm-3
Plt > 100,000/mm-3
Hb > 9.0 g/dL-1
neutro > 2,000 mm-3
AST(GOT), ALT(GPT)< 2.5x upper normal limit
T-Bil< 1.5x upper normal limit
creatinine clearance > 45 ml/min
SpO2> 93%
Urinari protein <= 1+ or 2g/24hrs
9)a life expectancy of 3 months or more
10)Written informed consent
Key exclusion criteria
1)Uncontrolled infection or Serious medical complications
2)massive pleural effusion or ascites. (accept controrable pleural effusion with OK-432)
3)current or previous treated brain metastasis
4)severe cardiac disease
5)uncontrolled diabetes mellitus
6)receiving anticoagulant drug(except Aspirin under 325mg/day)
7)current or previous history of hemoptysis(>=2.5ML) due to NSCLC
8)history of hemoptysis(over 1 week) or receive oral/i.v. hemostatic drug
9)uncontrolled hyper tension
10)current or previous (within the last 1 year) history of GI perforation
11)interstitial pneumonia or lung
fibrosis evident on CT
12)history of drug induced interstitial pneumonia
13)Patient who has been scheduling operation for examination period
14)treatment history of carboplatin, pemetrexed and bevacizumab
15)severe drug allergy
16)Patient who cannot or doesn't hope administer multivitamin and vitamin B12
17)active concomitant malignancy
18)severe psychological disease
19)pregnant or lactating women or those who declined contraception
20)those judged to be not suitable by the attending physician
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | TAKASHI YOKOI |
Organization
Kansai Medical University Hirakata Hospital
Division name
respiratory medicine
Zip code
Address
2-3-1, Shinmachi, Hirakata-city, OSAKA
TEL
072-804-0101
yokoit@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Yokoi |
Organization
Kansai Medical University Hirakata Hospital
Division name
respiratory medicine
Zip code
Address
2-3-1 Shinmachi,Hirakata,Osaka,Japan
TEL
072-804-0101
Homepage URL
yokoit@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University Hirakata Hospital
Institute
Department
Personal name
Funding Source
Organization
Kansai Medical University Hirakata Hospital
Organization
Division
Category of Funding Organization
Self funding
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
関西医科大学附属枚方病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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 | 03 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | 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 | 03 | Month | 27 | Day |
Last modified on
| 2017 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004112
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