UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005214 |
|---|---|
| Receipt number | 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 17:37:05 |
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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
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
Sponsor or person
Institute
Cancer Institute Ariake Hospital of JFCR
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006105
