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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004609
Receipt No. 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

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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
Email 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
Email ytakeda@hosp.ncgm.go.jp

Sponsor
Institute Shinjuku Thoracic Oncology Group
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005494

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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