UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004685 |
|---|---|
| Receipt number | R000005568 |
| Scientific Title | Phase II study of Combination Therapy of Pemetrexed/Carboplatin/Bevacizumab for Advanced Non-small-cell lung cancer |
| Date of disclosure of the study information | 2010/12/09 |
| Last modified on | 2019/02/16 15:38:03 |
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Basic information
Public title
Phase II study of Combination Therapy of Pemetrexed/Carboplatin/Bevacizumab
for Advanced Non-small-cell lung cancer
Acronym
Phase II study of Combination Therapy of Pemetrexed/Carboplatin/Bevacizumab
for Advanced Non-small-cell lung cancer
Scientific Title
Phase II study of Combination Therapy of Pemetrexed/Carboplatin/Bevacizumab
for Advanced Non-small-cell lung cancer
Scientific Title:Acronym
Phase II study of Combination Therapy of Pemetrexed/Carboplatin/Bevacizumab
for Advanced Non-small-cell lung cancer
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
Investigation of efficacy and safety of combination therapy of Pemetrexed/Carboplatin/Bevacizumab and Bevacizumab maintenance therapy
for Advanced Non-small-cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
responce rate
Key secondary outcomes
safety, progression free survival, over all survival
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 Bevacizumab(15mg/kg, div), Pemetrexed(500mg/m2, div) and Carboplatin(AUC=5, div) on day 1, every 4 weeks, up to 6 cycles. Patients who get efficacy above SD without unacceptable toxity, then continuously are treated with Bevacizumab(15mg/kg, div) on day 1, every 4 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 confirmed non-squamous non-small-cell lung cancer
2)chemotheraoy naive patients or postoperative recurrence patients without adjuvant chemotherapy excluded UFT treatment
3) stage IIIB/IV(UICC-7) or postoperative recurrence patients
4)mesurrable leision
5)ECOG performance status of 0-2
6)age: 20-75
7)adequate major organ (hemoatologic hepatic, respiratory and renal function) function
white blood cell >=3000/mm3
hemoglobin >=9.5g/dl
platelet >=100000/mm3
total bilirubin <= 1.5
AST/ALT <=2.5 times upper limit of normal
PaO2 >=65 torr or SpO2 >=92%
8)life expectancy more than 3 months
9)written informed consent
Key exclusion criteria
1)Uncontrolled complication
unstable angina or myocardiac infarction within 3 months
uncontrolled DM and hypertension
uncontrolled infection
active interstitial pneumonia
active gastiric ulcer
active concominant cancer
illeus
2)patients who cannot been given Bevacizumab
with great vessel invasion
cavity in tumor
current or previous histoty ofhemoptysis(2.5ml)due to NSCLC
receiving anticoagulant drug(except Aspirin under 325mg/day)
untreated current brain metastasis
3)history of sever allergy
4)severe SVC syndrome
5)uncontrolled malignant pleuritis
6)history of pregnancy or lactation
7)Patients whose participation in the trial is judged to be inappropriate by the attending doctor
Target sample size
38
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | ogura shigeaki |
Organization
National Hospital Organization Hokkaido Medical Center
Division name
Department of Respiratory Medicine
Zip code
Address
yamanote 5-7, Nishi-ku, sapporo
TEL
011-611-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | ogura shigeaki |
Organization
National Hospital Organization Hokkaido Medical Center
Division name
Department of Respiratory Medicine
Zip code
Address
yamanote 5-7, Nishi-ku, sapporo
TEL
011-611-8111
Homepage URL
sogura@hok-mc.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Hokkaido Medical Center
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
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
北海道医療センター（北海道）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 12 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 08 | Day |
Last modified on
| 2019 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005568
