UMIN-CTR Clinical Trial

Basic information
Public title	A phase II study of Carboplatin+Pemetrexed +Bevacizumab for gefitinib refractory NSCLC patients with mutated EGFR
Acronym	A phase II study of Carboplatin+Pemetrexed +Bevacizumab for gefitinib refractory NSCLC patients with mutated EGFR
Scientific Title	A phase II study of Carboplatin+Pemetrexed +Bevacizumab for gefitinib refractory NSCLC patients with mutated EGFR
Scientific Title:Acronym	A phase II study of Carboplatin+Pemetrexed +Bevacizumab for gefitinib refractory NSCLC patients with mutated EGFR
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the he response rate and feasibility of Carboplatin+Pemetrexed+Bevacizumab in patients with Gefitinib refractory 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 II

Assessment
Primary outcomes	Response rate
Key secondary outcomes	progression free survival, overall survival, time to response, safety

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	Carboplatin+Pemetrexed+Bevacizumab every 3 weeks. Responding patients receive Pemetrexed+Bevacizumab maintenance.
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1. histologically or cytologically confirmed non-squamous NSCLC 2. Stage IIIB, VI or recurrent post operative patients 3. measurable disease 4. life expectancy of at least 3 months. 5. 20>=age >75 years 6. performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale 7. adequate organ function adequate bone marrow (neutrophil count > =1,500/mm3, hemoglobin concentration > =9.0g/dL, platelet count >= 100,000 /mL), kidney (creatinine>= Cr 60), liver (aspartate aminotransferase [AST] and alanine aminotransferase [ALT] < =institutional normal level x 2.5, total bilirubin< =institutional normal level x 1.5 ), SpO2> =93, Proteinuria< 2g 8. positive sensitizing EGFR mutations
Key exclusion criteria	1. Radiation therapy to primary cancer 2.Active infection or other serious conditions 3. Severe pleural effusion or uncontrollable pleural effusion 4.Symptomatic brain metastasis 5. Uncontrollable hypertension 6. Uncontrollable diabetes mellitus 7. Current or previous history of hemoptysis or hemosputum 8. Current or previous (within the last 1 year) history of GI perforation 9. Interstitial pneumonia or pulmonary fibrosis detectable on CT scan 10.Tumor invasive to the chest large blood vessel. 11.Evidence of bleeding diathesis or coagulopathy 12.History of active double cancer 13.History of active psychological disease 14.History of pregnancy or lactation 15. Active concomitant malignancy 16. Active mental illness 17. Previous treatment with Carboplatin or Pemetrexed or Bevacizumab 18. History of severe heart disease(uncontrollable arrythmia,uncontrollable angina pectoris etc)
Target sample size	28

Research contact person
Name of lead principal investigator	1st name Hirohisa Middle name Last name Yoshizawa
Organization	Niigata University Medical and Dental Hospital
Division name	Bioscience Medical Research Center
Zip code	951-8510
Address	1-754 Asahimachi-Dori,Niigata City, Niigata 951-8520
TEL	025-227-2517
Email	hy0522@med.niigata-u.ac.jp

Public contact
Name of contact person	1st name Hirohisa Middle name Last name Yoshizawa
Organization	Niigata University Medical and Dental Hospital
Division name	Bioscience Medical Research Center
Zip code	951-8510
Address	1-754 Asahimachi-Dori,Niigata City, Niigata 951-8520
TEL	025-227-2517
Homepage URL
Email	hy0522@med.niigata-u.ac.jp

Sponsor
Institute	Niigata Lung Cancer Treatment Group
Institute
Department

Funding Source
Organization	Niigata Foundation for the Promotion of Medicine
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	Niigata university Institutional review board
Address	1-757 Asahimachi-dori, Niigata-city, Japan
Tel	025-227-2439
Email	shinki-center@adm.niigata-u.ac.jp

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	燕労災病院（新潟県） 厚生連長岡中央綜合病院（新潟県） 国立病院機構西新潟中央病院（新潟県） 済生会新潟第二病院（新潟県） 上越総合病院（新潟県） 新潟県立がんセンター（新潟県） 新潟県立吉田病院（新潟県） 新潟県立新発田病院（新潟県） 新潟県立中央病院（新潟県） 新潟市民病院（新潟県） 新潟大学医歯学総合病院（新潟県） 新潟労災病院（新潟県） 長岡赤十字病院（新潟県）

Other administrative information
Date of disclosure of the study information	2010 Year 12 Month 08 Day

Related information
URL releasing protocol	NA
Publication of results	Unpublished

Result
URL related to results and publications	NA
Number of participants that the trial has enrolled	35
Results	NA
Results date posted	2019 Year 06 Month 21 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	NS
Participant flow	NA
Adverse events	NA
Outcome measures	NA
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2010 Year 08 Month 25 Day
Date of IRB	2012 Year 08 Month 01 Day
Anticipated trial start date	2012 Year 08 Month 01 Day
Last follow-up date	2015 Year 08 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2010 Year 12 Month 08 Day
Last modified on	2019 Year 06 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005575