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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006514
Receipt No. R000007725
Scientific Title Phase II trial of irinotecan, paclitaxel plus bevacizumab for previously untreated patients with non-squamous and non-small cell lung cancer, detected the over-expression of ERCC1 by EBUS-GS.
Date of disclosure of the study information 2011/10/12
Last modified on 2017/11/20

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Basic information
Public title Phase II trial of irinotecan, paclitaxel plus bevacizumab for previously untreated patients with non-squamous and non-small cell lung cancer, detected the over-expression of ERCC1 by EBUS-GS.
Acronym Phase II trial of irinotecan, paclitaxel plus bevacizumab for patients with NSCLC
Scientific Title Phase II trial of irinotecan, paclitaxel plus bevacizumab for previously untreated patients with non-squamous and non-small cell lung cancer, detected the over-expression of ERCC1 by EBUS-GS.
Scientific Title:Acronym Phase II trial of irinotecan, paclitaxel plus bevacizumab for patients with NSCLC
Region
Japan

Condition
Condition non-small cell lung cancer
Classification by specialty
Pneumology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 efficacy
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes response rate
Key secondary outcomes

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 irinotecan 50mg/m2
paclitaxel 180mg/m2
bevacizumab 15mg/kg
every 4weeks more than 3cycles
maintenance of bevacizumab 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
75 years-old >
Gender Male and Female
Key inclusion criteria 1)non-squamou and non-small cell lung cancer with over-expression of ERCC1
2)not having homo-UGT1A1*6 and *28
3)stage IIIB or IV without indication of radiation
4)previously untreated patients without EGFR-TKIs
5)ECOG PS 0-1
6)having measurable lesions according to RECIST(version1.1)
7)adequate kidney, liver, bone marrow functions
8)expecting the survival period more than 12 weeks
9)written informed consent
Key exclusion criteria 1)brain metastasis
2)cavity lesion
3)invasion of giant vessels
4)hemoptysis
5)history of radiotherapy for lung
6)interstitial pneumonitis
7)watery diarrhea
8)severe gastrointestinal disease
9)uncontrollable fever up
10)other sever disease
11)uncontrollable pericardial,pleural effusion and ascites
12)other carcinoma
13)sever allergy history
14)receiving anti-coagulate treatment without biaspilin
15)psychological disease
16)women with pregnant or under lactation
17)others diagnosed as inadequate case to enter the trial

Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoichi Nakamura
Organization Nagasaki University School of Medicine
Division name Second Department of Internal Medicine
Zip code
Address 1-7-1 Sakamoto, Nagasaki
TEL 095-819-7273
Email yi-nakamu@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nakamura Yoichi
Organization Nagasaki University School of Medicine
Division name Second Department of Internal Medicine
Zip code
Address 1-7-1 Sakamoto, Nagasaki
TEL 095-819-7273
Homepage URL
Email yi-nakamu@umin.ac.jp

Sponsor
Institute Nagasaki Thoracic Oncology Group
Institute
Department

Funding Source
Organization NEOCI
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 10 Month 12 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 Completed
Date of protocol fixation
2011 Year 09 Month 06 Day
Date of IRB
Anticipated trial start date
2011 Year 10 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 10 Month 10 Day
Last modified on
2017 Year 11 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007725

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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