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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000005214
Receipt No. R000006105
Scientific Title A randomized phase II study of a combination of docetaxel and bevacizumab versus docetaxel monotherapy in patients with non-small cell lung cancer previously treated with bevacizumab and platinum-based chemotherapy.
Date of disclosure of the study information 2011/03/08
Last modified on 2012/09/10

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Basic information
Public title A randomized phase II study of a combination of docetaxel and bevacizumab versus docetaxel monotherapy in patients with non-small cell lung cancer previously treated with bevacizumab and platinum-based chemotherapy.
Acronym A randomized phase II study of a combination of docetaxel and bevacizumab versus docetaxel monotherapy in patients with non-small cell lung cancer previously treated with bevacizumab and platinum-based chemotherapy.
Scientific Title A randomized phase II study of a combination of docetaxel and bevacizumab versus docetaxel monotherapy in patients with non-small cell lung cancer previously treated with bevacizumab and platinum-based chemotherapy.
Scientific Title:Acronym A randomized phase II study of a combination of docetaxel and bevacizumab versus docetaxel monotherapy in patients with non-small cell lung cancer previously treated with bevacizumab and platinum-based chemotherapy.
Region
Japan

Condition
Condition Lung cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the safety and efficacy of Docetaxel vs Docetaxel and Bevacizumab in a phase II clinical study of patients with treated advanced NSCLC.

Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes PFS
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Bevacizumab and Docetaxel
Interventions/Control_2 Docetaxel
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 Histologically or cytrologically confirmed diagnosis of NSCLC with a adeno or large cell carcinoma.
Patients must have had progressive disease after Bevacizumab and platinum-based chemotherapy;consisting of minimum of one cycle of maintenance
Previous treatment within 6 weeks from 3 week of study enrollment.
Tumors must have measurable disease by RECIST version 1.1
20 years of age or older.
ECOG performance status 0 or 1.
Any major surgery within 4 weeks of study enrollment.
No radiotherapy within 2 weeks of study enrollment.
No problem adequate organ function.


Key exclusion criteria Subjects with interstitial pneumonia or pulmonary fibrosis.
Uncontrolled Active infection.
Subjects with brain metastases.
Concurrent use of steroid therapy.
Uncontrolled pleural.
Subjects with previous malignancies.
Any other reason that,in the opinion of the investigator precludes the subject from participating in the study.

Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Nishio
Organization Cancer Institute Ariake Hospital of JFCR
Division name Toracic Medical Oncology
Zip code
Address 3-8-31,Ariake Koutou-ku Tokyo,Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Fumiyoshi.Ohyanagi
Organization Cancer Institute Ariake Hospital of JFCR
Division name Toracic Medical Oncology
Zip code
Address 3-8-31,Ariake Koutou-ku Tokyo,Japan
TEL
Homepage URL
Email

Sponsor
Institute Cancer Institute Ariake Hospital of JFCR
Institute
Department

Funding Source
Organization Cancer Institute Ariake Hospital of JFCR
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
2011 Year 03 Month 08 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 03 Month 02 Day
Date of IRB
Anticipated trial start date
2011 Year 04 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 03 Month 08 Day
Last modified on
2012 Year 09 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006105

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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