UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of pemetrexed or pemetrexed plus bevacizumab for previously untreated elderly non-squamous non-small cell lung cancer
Acronym	Phase II trial of PEM or PEM/BEV
Scientific Title	Phase II study of pemetrexed or pemetrexed plus bevacizumab for previously untreated elderly non-squamous non-small cell lung cancer
Scientific Title:Acronym	Phase II trial of PEM or PEM/BEV
Region	Japan

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

Objectives
Narrative objectives1	To determine efficacy and safety of pemetrexed or pemetrexed/bevacizumab for previously untreated elderly non-squamous non-small cell lung cancer and the regimen for phase III study
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Progression free survival
Key secondary outcomes	Response, Overall survival, Adverse effect, Cost effectiveness

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Pemetrexed
Interventions/Control_2	Pemetrexed plus bevacizumab
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) histologically confirmed diagnosis of NSqNSCLC; 2) no prior chemotherapy or molecular targeted therapy 3) stage IIIB or IV with no indication of radical radiotherapy, or recurrence after operation 4) no active overlapping cancer 5) age >=75 years 6) Eastern Cooperative Oncology Group (ECOG) performance status (PS)0-1 7) adequate organ function (leukocyte count >=4,000/mm3, hemoglobin level >=9 g/dl, platelet count >=100,000/mm3, ALT and AST levels <100 IU/L,serum bilirubin level =<1.5 mg/dl,serum creatinine level=<1.5 mg/dl,proteinurea =<1+ and PaO2 >=60 Torr (or SpO2 >=90) 8) evaluable lesion 9) informed consent 10) life expectancy greater than 3 months
Key exclusion criteria	1) symptomatic brain metastasis 2) complications as follows: hemoptysis, arterial and venous thromboembolism, uncontrolled hypertension, perforation of the digestive tract/severe fistula/bronchoesophageal fistula, inflammation in abdominal cavity, congenital bleeding predisponency/abnormality of hemostasis, uncontrolled diabetes 3) operation within 28 days 4) planning of thoracic radiotherapy in bevacizumab therapy 5) symptomatic pericardial effusion 6) symptomatic SVC syndrome 7) interstitial pneumonia confirmed in chest X-ray 8) psychotic disease judged should not to participate the trial 9) other inadequacy cases judged by attending physician
Target sample size	82

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yukito Ichinose
Organization	National Kyusyu Cancer Center
Division name	Clinical Research Center
Zip code
Address	3-1-1 Nodame, South, Fukuoka, ZIP811-1395, Japan
TEL	092-541-3231
Email	yichinos@nk-cc.go.jp

Public contact
Name of contact person	1st name Middle name Last name Minoru Fukuda
Organization	Japanese Red Cross Nagasaki Genbaku Hospital
Division name	Department of Respiratory Diesease
Zip code
Address	3-15 Mori, Nagasaki, 852-8511, Japan
TEL	095-847-1511
Homepage URL
Email	mifukuda258@nifty.com

Sponsor
Institute	Lung Oncology Group in Kyushu, Japan (LOGIK)
Institute
Department

Funding Source
Organization	Clinical Research Support Center Kyushu
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2012 Year 08 Month 27 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	2012 Year 04 Month 01 Day
Date of IRB	2014 Year 04 Month 28 Day
Anticipated trial start date	2012 Year 08 Month 27 Day
Last follow-up date	2017 Year 10 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2018 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2012 Year 08 Month 26 Day
Last modified on	2021 Year 02 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010308