UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004609 |
|---|---|
| Receipt number | R000005494 |
| Scientific Title | A cohort study on practical treatment combined with bevacizumab in patients with non-small cell lung cancer (NSCLC) excluding squamous cell lung cancer |
| Date of disclosure of the study information | 2010/12/01 |
| Last modified on | 2018/05/09 16:26:44 |
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Basic information
Public title
A cohort study on practical treatment combined with bevacizumab in patients with non-small cell lung cancer (NSCLC) excluding squamous cell lung cancer
Acronym
A cohort study on bevacizumab combined treatment for non-squamous NSCLC
Scientific Title
A cohort study on practical treatment combined with bevacizumab in patients with non-small cell lung cancer (NSCLC) excluding squamous cell lung cancer
Scientific Title:Acronym
A cohort study on bevacizumab combined treatment for non-squamous NSCLC
Region
| Japan |
Condition
Condition
Stage IIIB or IV; locally advanced, metastatic, or recurrent non-squamous non small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine safety and efficacy for chemotherapy with bevacizumab in patients with advanced 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 IV
Assessment
Primary outcomes
Safety and efficacy (progression free survival)
Key secondary outcomes
Response rate, Time to response, Individual side effect and efficacy, Landmark analysis
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Histologically or cytologically proven non-small and non-squamous cell lung cancer
2.Stage IIIB/IV by UICC ver.7 or recurrence after surgical treatment
3.Tolerable for chemotherapy of non-small cell lung cancer
4.Eastern Cooperative Oncology Group performance status of 0-2
5.Duration requested after below treatment;
Palliative irradiation; >=2 weeks
Surgical operation; >= 4 weeks
Chest drainage; >= 2 weeks
Incisional biopsy, Implant of port, Treatment for injury; >=2 weeks
Aspiration biopsy; >= one week
6.Adequate organ function
Leukocyte count 3,000-12,000/mm^3
Neutrocyte count; >=1,500/mm^3
Platelet count; >= 100,000/mm^3
Hemoglobin concentration; >= 9.0 g/dL
AST and ALT; less than 2.5 times of the institutional upper limits of normal level
Total bilirubin level <=1.5 mg/dL
Creatinine clearance; >= 45mL/min
SpO2; >= 90%
Proteinurea ; <=1+ or 2 g / 24hrs
7.Written informed consent
Key exclusion criteria
Exclusion criteria included:
1.Patient with squamous cell lung cancer
2.Radiological evidence of tumor invading or abutting major blood vessels and evidence of brain metastases, even if previously treated. But eligible for disappeared or controlled brain metastases
3.Significant comorbid disease; active infection, arrhythmia, severe heart disease, elevated electrocardiogram abnormality, uncontrolled diabetes mellitus, other uncontrolled disease
4. A history of significant hemoptysis; >= 2.5 mL red blood per episode within 3 months before enrolment
5.A history of continuous hemoptysis over one week, or hemoptysis receiving oral or intravenous hemostatic drug
6. Uncontrolled hypertension
7. Perforation of gastrointestinal tract within one year
8. The operation has been scheduled for the examination period
9. A history of allergic reaction for the treatment drugs
10. Active concomitant malignancy
11. Pregnant or lactating women, couple wishing pregnant or no mind of prevent pregnancy
12. Other concominant medical condition deemed to inadequate for inclusion to the study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichiro Takeda |
Organization
National Center for Global health and Medicine
Division name
Department of respiratory medicine
Zip code
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan
TEL
03-3202-7181
ytakeda@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichiro Takeda |
Organization
National Center for Global health and Medicine
Division name
Department of respiratory medicine
Zip code
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan
TEL
03-3202-7181
Homepage URL
ytakeda@hosp.ncgm.go.jp
Sponsor or person
Institute
Shinjuku Thoracic Oncology Group
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
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
東京医科大学 外科学第一講座（東京都）
国立国際医療研究センター病院 呼吸器科（東京都）
慶應義塾大学医学部 呼吸器内科（東京都）
東京女子医科大学 化学療法・緩和ケア科（東京都）
東京女子医科大学 呼吸器内科（東京都）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.spandidos-publications.com/ol/archive.jsp
Number of participants that the trial has enrolled
Results
Combination chemotherapy with Bev was effective for the patients with non-sq NSCLC in real-world clinical practice as similar efficacy as clinical trials.
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
| 2010 | Year | 09 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 10 | Month | 30 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 31 | Day |
Other
Other related information
Multicenter prospective observational study
Management information
Registered date
| 2010 | Year | 11 | Month | 23 | Day |
Last modified on
| 2018 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005494
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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