UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011615 |
|---|---|
| Receipt number | R000013539 |
| Scientific Title | A pilot study of Pemetrexed, Platinum agent plus Bevacizumab for advanced non-squamous non-small cell lung cancer with brain metastases |
| Date of disclosure of the study information | 2013/08/31 |
| Last modified on | 2015/03/05 17:50:07 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A pilot study of Pemetrexed, Platinum agent plus Bevacizumab for advanced non-squamous non-small cell lung cancer with brain metastases
Acronym
A pilot study of Pemetrexed, Platinum agent plus Bevacizumab for advanced non-squamous non-small cell lung cancer with brain metastases
Scientific Title
A pilot study of Pemetrexed, Platinum agent plus Bevacizumab for advanced non-squamous non-small cell lung cancer with brain metastases
Scientific Title:Acronym
A pilot study of Pemetrexed, Platinum agent plus Bevacizumab for advanced non-squamous non-small cell lung cancer with brain metastases
Region
| Japan |
Condition
Condition
Advanced non-squamous NSCLC
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate of efficacy and safety of Bevacizumab-combined platinum doublet chemotherapy for patients of non-squamous NSCLC with brain metastases
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Response rate
Key secondary outcomes
any CNS adverse effects
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 or CBDCA + pem+bev followed by pem+bev 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. aged 20 years or over
2. stageIV or recurrence of post operative patient
3. pathologically confirmed non- squamous NSCLC
4. Patients with life expectancy for more than 3 months
5. Performance Status 0-1
6. treated with radiotherapy or surgery to brain metastases
7. untreated patients without EGFR-TKI
8. measurable or nonmeasurable disease
9. Patients with adequate organ function as following
Neutrophil count >= 1500/mm3
Platelet count >= 100,000/mm3
Hemoglobin >= 9.0 g/dL
Aspartate aminotransferase and alanine aminotransferase < 2.5 times the upper limit of normal
Total bilirubin <= 1.5mg/dL
Serum creatinine <= 1.5mg/dL
PT-INR<1.5
Ccr>=60mL/min(CDDP), 45mL/min(CBDCA)
Urine protein<=+1
10. No Exploratory thoracotomy within 4 weeks
No pleural drainage within 2 weeks
11. Written informed consent can be obtained.
Key exclusion criteria
1. symptomatic brain metastasis
2. history or complication of hemoptysis.
3. history of severe drug allergy
4. uncontrolled ascites, pleural effusion, or pericardial effusion
5. history of gastrointestinal perforation within one year, or a complication
6. uncontrolled hypertension
7. active infection requiring systemic administration of antiviral agents, antifungal agents, or antibiotics
8. antipletet therapy for chronic disease
9. irradiation to the chest or more than 20% region of bones
10. multiple cancer within 5 years
11. serious complications
12. pregnancy or lactation
13. inappropriate for this study judged by the attending physician
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuyuki Morikawa |
Organization
Yokohama Rosai Hospital
Division name
Department of Pulmonary Medicine
Zip code
Address
3211 Kozukue-cho, Kohhoku-ku, Yokohama City, Kanagawa 222-0036, Japan
TEL
045-474-8111
cix85250@rio.odn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Uehara |
Organization
Yokohama Rosai Hospital
Division name
Department of Pulmonary Medicine
Zip code
Address
3211 Kozukue-cho, Kohhoku-ku, Yokohama City, Kanagawa 222-0036, Japan
TEL
045-474-8111
Homepage URL
takashiu@yokohamah.rofuku.go.jp
Sponsor or person
Institute
Yokohama Rosai Hospital
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | Month | 31 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 31 | Day |
Last modified on
| 2015 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013539
