UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006532 |
|---|---|
| Receipt number | R000007721 |
| Scientific Title | A phase II study of Docetaxel with Bevacizumab for EGFR mutation negative previously treated non-squamous non-small cell lung cancer |
| Date of disclosure of the study information | 2011/10/14 |
| Last modified on | 2019/04/25 13:27:50 |
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Basic information
Public title
A phase II study of Docetaxel with Bevacizumab for EGFR mutation negative previously treated non-squamous non-small cell lung cancer
Acronym
A phase II study of Docetaxel with Bevacizumab for EGFR mutation negative previously treated non-squamous non-small cell lung cancer
Scientific Title
A phase II study of Docetaxel with Bevacizumab for EGFR mutation negative previously treated non-squamous non-small cell lung cancer
Scientific Title:Acronym
A phase II study of Docetaxel with Bevacizumab for EGFR mutation negative previously treated non-squamous non-small cell lung cancer
Region
| Japan |
Condition
Condition
Non-Squamous Non-Small Cell Lung Cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Investigation of the efficacy and safety of Docetaxel with Bevacizumab for EGFR mutation negative previously treated non-squamous non-small cell lung cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Progression Free Survival
Key secondary outcomes
Response Rate
Disease Control Rate
Overall Survival
Maximum tumor volume change
Safety Profile
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
Docetaxel with Bevacizumab
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. Histologically or cytologically confirmed non-squamous non-small cell lung cancer
2. Clinical stage : IIIB/IV
3. 20<= years <70
4. Performance status (ECOG) : 0-2
5. Relapsed or progressed to one or more prior chemotherapy
6. Less than 4 weeks observation since relapse or progression.
7. No prior treatment with Docetaxel.
8. With one or more measurable disease based on RECIST
9. Adequate function of vital organs as following:
Neutrophils >= 1,500/mm3
Hemoglobin >= 9.0 g/dL
Platelets >= 75,000/mm3
AST and ALT <= 2.5ULN
Total bilirubin <= 1.5ULN
Serum albumin <= 2.5mg/dL
Serum creatinine <= 1.2mg/dL
Creatinine Clearance >= 45ml/min
Urinary protein <= 1+
10. No chemotherapy within 21days prior to the study.
No thoracic radiotherapy within 28days prior to the study.
No radiotherapy (except thoracic) within 7days prior to the study.
No G-CSF within 7days prior to study.
No pleurodesis, pleural drainage etc. within 14days prior to the study
11. A life expectancy of more than 3 months
12. Written informed consent before initiation of study-related procedures
Key exclusion criteria
1. EGFR mutation status positive
2. CNS metastasis
3. History or complication of hemoptysis with 2.5mL per time or more. Continuouis bloody phlegm more than 1 week. History or complication of bloody phlegm treated with continuous oral hemostatic agent. History or complication of bloody phlegm treated with infusional hemostatic agent.
4. Tendency to hemorrhages
5. continuous medication with anticoagulant drug(including Aspirin over 325mg/day) for Thrombus treatment
6. Invasion to major vessel or cavitations of tumor
7. Planning of concurrent thoracic radiotherapy (excluding if radiation field does not cover the chest
8. Pericardial effusion requiring drainage
9. Superior vena cava syndrome
10. Uncontrollable peptic ulcer
11. History of GI perforation
12. Uncontrollable hypertension
13. Symptomatic congestive heart failure, Unstable angina, arrhythmia requiring treatment
14. Severe myelosuppression
15. Severe infection
16. Severe psychological illness
17. Interstitial pneumonia or pulmonary fibrosis detectable on X ray.
18. With a history of drug sensitivity for Docetaxcel or Bevacizumab.
19. In pregnancy, during breast feeding, or possibility of pregnancy.
20. Any other medical condition that makes the patient unsuitable for inclusion in the study according to the opinion of the investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tetsuo |
| Middle name | |
| Last name | Shimizu |
Organization
Nihon University School of Medicine
Division name
Respiratory Medicine
Zip code
173-8610
Address
30-1 Ohyaguchi kami-machi, Itabashi-ku, Tokyo, Japan
TEL
03-3972-8111
shimizu.tetsuo@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuo |
| Middle name | |
| Last name | Shimizu |
Organization
Nihon University School of Medicine
Division name
Respiratory Medicine
Zip code
173-8610
Address
30-1 Ohyaguchi kami-machi, Itabashi-ku, Tokyo, Japan
TEL
03-3972-8111
Homepage URL
shimizu.tetsuo@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nihon University
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
Nihon University School of Medicine
Address
30-1 Ohyaguchi kami-machi, Itabashi-ku, Tokyo, Japan
Tel
03-3972-8111
hirukawa.yasuko@nihon-u.ac.jp
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
日本大学医学部附属板橋病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 10 | Month | 14 | 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 | 05 | Month | 27 | Day |
Date of IRB
| 2011 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 05 | Month | 31 | Day |
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 | 13 | Day |
Last modified on
| 2019 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007721
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| Registered date | File name |
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| Registered date | File name |
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