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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004573
Receipt No. R000005455
Scientific Title Phase II trial of paclitaxel plus bevacizumab for recurrent non-squamous non-small cell lung cancer
Date of disclosure of the study information 2010/11/17
Last modified on 2014/04/24

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Basic information
Public title Phase II trial of paclitaxel plus bevacizumab for recurrent non-squamous non-small cell lung cancer
Acronym Phase II trial of paclitaxel plus bevacizumab for recurrent non-squamous non-small cell lung cancer
Scientific Title Phase II trial of paclitaxel plus bevacizumab for recurrent non-squamous non-small cell lung cancer
Scientific Title:Acronym Phase II trial of paclitaxel plus bevacizumab for recurrent non-squamous non-small cell lung cancer
Region
Japan

Condition
Condition Non-small-cell lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation of the efficacy of paclitaxel plus bevacizumab for recurrent non-squamous non-small cell lung cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Three-months progression free rate
Key secondary outcomes Overall response rate
Overall survival
Toxicity

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Paclitaxel at a dose of 200mg/m2 and bevacizumab 15mg/kg were administrated every 21 days until disease progression, unacceptable toxicity, patient refusal, alternate treatment, or investigator's decision to remove patient from study.
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-squamous non-small-cell lung cancer with histologic or cytologic evidence.
2) Clinical stage IV
3) Previously treated with more than one systemic chemotherapy
4) Age >=20, <75
5) ECOG performance status <=2
6) Adequate organ functions like below
WBC >=3000/mm3
Neutrophil count >=1500/mm3
Platelet count >=100000/mm3
Serum creatinine <=1.2mg/dl
Total bilirubin <=1.5mg/dl
AST <=80IU/l
ALT <=80IU/l
PaO2 >=60Torr or SpO2 >90%
7) Written informed consent
Key exclusion criteria 1) Previously treated with paclitaxel and / or bevacizumab
2) Patients with brain metastasis
3) Patients with hemoptysis
4) Patients receiving therapeutic anticoagulation
5) Patients with complications like below
Active infection
Acute myocardial infarction during recent 6 months or the other severe heart disease
Uncontrollable diabetes mellitus
Uncontrollable hypertension
Active psychological disease
6) Hypersensitivity to paclitaxel and / or bevacizumab
7) Active concomitant malignancy
8) Pregnancy or lactation
9) Inappropriate patients for this study judged by the physicians
Target sample size 42

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shintaro Kanda
Organization Shinshu University School of Medicine
Division name First Department of Internal Medicine
Zip code
Address 3-1-1 Asahi, Matsumoto, Nagano 390-8621 Japan
TEL 0263-37-3631
Email shintarokanda@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Shintaro Kanda
Organization Shinshu University School of Medicine
Division name First Department of Internal Medicine
Zip code
Address 3-1-1 Asahi, Matsumoto, Nagano 390-8621 Japan
TEL 0263-37-3631
Homepage URL
Email shintarokanda@gmail.com

Sponsor
Institute First Department of Internal Medicine, Shinshu University School of Medicine
Institute
Department

Funding Source
Organization First Department of Internal Medicine, Shinshu University School of Medicine
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
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
2010 Year 11 Month 17 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
2010 Year 11 Month 16 Day
Date of IRB
Anticipated trial start date
2010 Year 12 Month 01 Day
Last follow-up date
2014 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 11 Month 16 Day
Last modified on
2014 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005455

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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