UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006077 |
|---|---|
| Receipt number | R000007191 |
| Scientific Title | A phase II study of Conbination therapy of Carboplatin/Paclitaxel/Bavacizumab in previously untreated patients with StageIIIB/IV non-small cell lung cancer |
| Date of disclosure of the study information | 2011/07/30 |
| Last modified on | 2018/02/19 15:11:29 |
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Basic information
Public title
A phase II study of Conbination therapy of Carboplatin/Paclitaxel/Bavacizumab in previously untreated patients with StageIIIB/IV non-small cell lung cancer
Acronym
A phase II study of Conbination therapy of Carboplatin/Paclitaxel/Bavacizumab in previously untreated patients with StageIIIB/IV non-small cell lung cancer
Scientific Title
A phase II study of Conbination therapy of Carboplatin/Paclitaxel/Bavacizumab in previously untreated patients with StageIIIB/IV non-small cell lung cancer
Scientific Title:Acronym
A phase II study of Conbination therapy of Carboplatin/Paclitaxel/Bavacizumab in previously untreated patients with StageIIIB/IV non-small cell lung cancer
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate efficacy and safety of Carboplatin plus Paclitaxel and Bavacizumab in previously treated patients with StageIIIB/IV non- squamous non-small cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Progression free survival
Key secondary outcomes
Response rate, Adverse events, Overall survival, Response rate of each EGFR status
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 Carboplatin (AUC=6, div), Paclitaxel (200mg/m2) and Bevacizumab (15mg/kg, div) on day 1, every 3 weeks, up to 6 cycles. Patients who get efficacy above SD without unacceptable toxity, then continuously are treated with Paclitaxel (200mg/m2) and Bevacizumab (15mg/kg, div) on day 1, 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)histologically or cytologically confirmed non-squamous non-small-cell lung cancer
2)stage IIIB/IV or postoperative recurrence patients
3)chemotheraoy naive patients
4)Performance Status(ECOG) 0-1
5)Patient who has at least one or more measurable lesion by RECIST
6)Patients aged 20 years or older
7)Sufficient function of main organ and normal hematopoietic function, normal liver function and normal renal function filled the following criteria
*Leukocyte counts >= 3,000/mm3
*Neutrophil counts >= 1,500/mm3
*Platelets >= 100,000/mm3
*Hemoglobin concentration >= 9.0 g/dL
*AST and ALT, x 2.5 of upper limit of normal (ULN) or less.
*Total bilirubin <=1.5mg/dL.
*Serum creatinin, x 1.5 of ULN or less.
*Electrocardiogram Nomal
*SpO2 >=90% or SaPO2 >=65mmHg
*Protein urea >= 1+
8)Patients who are considered to survive for more than 3 months.
9)interval:
(1)Radiation
*More than 2 weeks after the last irradiation to other organs.
(2)Operation (including pleurodesis)
*More than 4 weeks after the operation without Lobectomy (including exploratory surgery)
*More than 2 weeks after the last operation (including pleurodesis)
10)Patients providing written informed consent
Key exclusion criteria
1)Patients with untreated Brain metastases
2)Patients with current or previous history of hemoptysis (2.5mL or more)
3)Patients with uncontrolled hyper tension
4)Patients with uncontrolled infection
5)Patients with active lung disease such as interstitial pneumonia, pneumoconiosis, active radiation pneumonitis, pulmonary fibrosis or drug-induced pneumonitis
6)Patients with uncontrollable complications
7)Patients with massive pleural or pericardial effusion,or ascites
8)Patients with active concomitant malignancy
9)Patients with previous histories of drug allergy
10)Patients with uncontrollable gastrointestinal ulceration
11)Patients with current or previous (within one year) history of gastrointestinal perforation
12)Patients with therapeutic anticoagulopathy (including Aspirin over 325mg/day)
13)Pregnancy or lactation
14)Inappropriate patients for this study judged by the physicians
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoko Shibata |
Organization
Yamagata University School of Medicine
Division name
Department of Cardiology, Pulmonology, and Nephrology
Zip code
Address
2-2-2 Iida-Nishi, Yamagata-shi,Yamagata 990-9585, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Yamagata University School of Medicine
Division name
Department of Cardiology, Pulmonology, and Nephrology
Zip code
Address
2-2-2 Iida-Nishi, Yamagata-shi,Yamagata 990-9585, Japan
TEL
023-628-5302
Homepage URL
Sponsor or person
Institute
Yamagata University School of Medicine
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
| 2011 | Year | 07 | Month | 30 | 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
| 2011 | Year | 05 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | 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 | 07 | Month | 29 | Day |
Last modified on
| 2018 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007191
