UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A cohort study on practical treatment combined with bevacizumab in patients with non-small cell lung cancer (NSCLC) excluding squamous cell lung cancer
Title of the study (Brief title)	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	Yuichiro Takeda
Organization	National Center for Global health and Medicine
Division name	Department of respiratory medicine
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	Yuichiro Takeda
Organization	National Center for Global health and Medicine
Division name	Department of respiratory medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 09 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.spandidos-publications.com/ol/archive.jsp
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.
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