UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Multicenter phase II study of Carboplatin/Pemetrexed/Bevacizumab in First-Line Treatment of Elderly Patients with Advanced Non-squamous and Non-small Cell Lung cancer
Title of the study (Brief title)	Phase II study of CBDCA/PEM/BEV in elderly NSCLC
Region	Japan

Condition
Condition	Non-squamous non-small cell lung cancer
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of the combination of CBDCA/PEM/BEV in elderly patients with non-sq NSCLC.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Response rate
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	CBDCA+PEM+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	75 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) In histological or cytological diagnosis, diagnosis of the non-squamous and non-small cell lung cancer is obtained 2) More than 75 years old at the time of the agreement acquisition 3) Eastern Cooperative Oncology Group (ECOG)Performance Status (PS) 0-1 4) With the measurable disease based on Response Evaluation Criteria in solid Tumors (RECIST) v. 1.1 5) There is not systemic chemotherapy history for non-squamous cell and small cell carcinoma, expect UFT for adjuvant therapy or therapy for pleurodesis and first line of EGFR-TKI or Crizotinib 6) With adequate organ function within one week before study entry 7) The expected survival more than 90 days from the enrollment 8) An agreement by the document from a patient
Key exclusion criteria	1) The case that there is previous treatment history 2) With the active double primary cancer 3) With the pleural effusion or pericardial effusion to need drainage 4) With the metastatic brain tumor to need treatment, such as radiotherapy or steroid 5) History of active hemoptysis with 2,5 ml or more 6) The case that a hemorrhage risk is high a) With the necessity of the administration of anticoagulant and antiplatelet agent b) With the the tumor invasion to great vessels c) With the cavity lesion 7) With the following complication or past history a) With the merger or history of cerebrovascular disease to need treatment b) With the history of perforation gastrointestinal, fistula, diverticulitis c) With the diarrhea, paresis of intestine, ileus d) With the merger or history of angina or myocardial infarction, cardiac failure to need treatment e) With the uncontrol diabetes f) With the interstitial pneumonia g) With the uncontrol infectious disease h) With the history of serious drug allergy i) With the uncontrol hypertension even if taking the hypotensive drug 8) With the mental disease 9) The patient whom attending physician judged to be inadequate to perform the study treatment safely
Target sample size	42

Research contact person
Name of lead principal investigator	Kazuhiko Yamada
Organization	Department of Internal Medicine, Kurume University School of Medicine
Division name	Division of Respirology, Neurology, and Rheumatology
Address	67 Asahi-machi, Kurume, Fukuoka
TEL	0942-31-7560
Email	kayamada@med.kurume-u.ac.jp

Public contact
Name of contact person	Kazuhiko Yamada
Organization	Department of Internal Medicine, Kurume University School of Medicine
Division name	Division of Respirology, Neurology, and Rheumatology
Address	67 Asahi-machi, Kurume, Fukuoka
TEL	0942-31-7560
Homepage URL
Email	kayamada@med.kurume-u.ac.jp

Sponsor
Institute	Kurume University School of Medicine
Institute
Department

Funding Source
Organization	Kurume University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	久留米大学病院（福岡県）、九州医療センター（福岡県）

Other administrative information
Date of disclosure of the study information	2013 Year 07 Month 02 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 06 Month 01 Day
Anticipated trial start date	2013 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 07 Month 02 Day
Last modified on	2018 Year 07 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012669