UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013329 |
|---|---|
| Receipt number | R000015553 |
| Scientific Title | Phase2 study of Carboplatin / Nab-paclitaxel + Bevacizumab to non-small-cell lung cancer (non-squamous cell carcinoma) with malignant pleural efussion |
| Date of disclosure of the study information | 2014/03/05 |
| Last modified on | 2021/01/25 18:24:30 |
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Basic information
Public title
Phase2 study of Carboplatin / Nab-paclitaxel + Bevacizumab to non-small-cell lung cancer (non-squamous cell carcinoma) with malignant pleural efussion
Acronym
Phase2 study of CBDCA / Nab-PAC + Bevacizumab to non-small-cell lung cancer with malignant pleural efussion
Scientific Title
Phase2 study of Carboplatin / Nab-paclitaxel + Bevacizumab to non-small-cell lung cancer (non-squamous cell carcinoma) with malignant pleural efussion
Scientific Title:Acronym
Phase2 study of CBDCA / Nab-PAC + Bevacizumab to non-small-cell lung cancer with malignant pleural efussion
Region
| Japan |
Condition
Condition
non-small-cell lung cancer (non-squamous cell carcinoma) with malignant pleural efussion in stage4
Classification by specialty
| Medicine in general | Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
we rospectivelyexamine the efficacy and safety of Carboplatin / Nab-Paclitaxel + bevacizumab to non-small-cell lung cancer (non-squamous cell carcinoma) with malignant pleural efussion in stage4
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
efficacy
Key secondary outcomes
Density of chest underwater VEGF before and after chemotherapy, overall survival time, safety, 1-year survival rate, progression free 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
Carboplatin/nab-paclitaxel+bevacizumab
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)Histologically or cytologically confirmed Stage IV Non-small-cell lung cancer
2)Non-Squamous Non-small-cell lung cancer
3)Malignant pleural effusion requiring drainage
4)Adjuvant chemotherapy is permitted
5)At least one year has to be past since the last administration of adjuvant chemotherapy
6)Age : 20 years or older
7)At least one measurable lesion by RECIST
8)PS : 0-2
9)adequate major organ (hemoatologic hepatic, respiratory and renal function) function
white blood cell >=3000/mm3
hemoglobin >=9.0g/dl
platelet >=100000/mm3
total bilirubin <= 1.5
AST/ALT <=2.0 times upper limit of normal
SpO2 >=90%
Adequate organ function
10)Life expectancy more than three months
11)Adequate interval since the last radiation therapy or surgery
12)written informed consent
Key exclusion criteria
1)History of pleurodesis or pleural effusion drainage
2)Severe infection except for non-active hepatitis C
3)Fever more than 38 degree
4)Severe comorbidity (heart failure/kidney failure/hepatic failure/uncontrollable diabetes/uncontrollable hypertension, etc)
5)Active double cancer
6)Symptomatic brain metastasis
7)History of hemoptysis with 2.5mL or more
8)Pericardial effusion requiring drainage
9)Interstitial pneumonia or pulmonary fibrosis detectable on X ray
10)History of drug sensitivity
11)Pregnant or lactating women
12)Psychiatric disease or mental trouble
13)Continuing administration of steroid
14)Evaluated to be ineligible by a physician for other reasons
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirashima Tomonori |
Organization
Osaka Prefectural Medical Center for Respiratory and Allergic diseases
Division name
Thoracic Malignancy
Zip code
Address
3-7-1 Habikino Habikino city Osaka
TEL
+81-729-57-2121
hirashimat@opho.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tamiya Motohiro |
Organization
Osaka Prefectural Medical Center for Respiratory and Allergic diseases
Division name
Thoracic Malignancy
Zip code
Address
3-7-1 Habikino Habikino city Osaka
TEL
+81-729-57-2121
Homepage URL
moto19781205@yahoo.co.jp
Sponsor or person
Institute
Osaka Prefectural Medical Center for Respiratory and Allergic diseases
Institute
Department
Personal name
Funding Source
Organization
Osaka Prefectural Medical Center for Respiratory and Allergic diseases
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
| 2014 | Year | 03 | Month | 05 | 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
| 2014 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2014 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2014 | Year | 03 | Month | 06 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 04 | Day |
Last modified on
| 2021 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015553
