UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of Pemetrexed plus Bevacizumab (YCRG04) in exacerbation cases of Non-squamous Non-small cell lung cancer, previously treated with bevacizumab plus platinum-based chemotherapy.
Title of the study (Brief title)	Phase II study of PEM plus Bevacizumab in patients with NSCLC previously treated with bevacizumab plus platinum-based chemotherapy (YCRG-04).
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 assess the safety and efficacy of Bevacizumab plus Pemetrexed in exacerbation cases of Non-squamous Non-small cell lung cancer, previously treated with bevacizumab plus platinum-based chemotherapy.
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	disease control rate, progression- free survival, overall survival, Time from the initination of previous treatment to the progression of disease after the treatment with this protocol, frequency of adverse events.

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	To continue chemotherapy with Bevacizumab plus Pemetrexed until the onset of ecxacerbation or intolerable adverse event.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1)>=20years-old 2)StageIIIB/IV unsuitable for radical irradiation or postoperative recurrent Non-Squamous NSCLC. 3)Documented disease progression after bevacizumab plus a platinum-based chemotherapy 4)Life expectancy>=3months 5)Eastern Cooperative Oncology Group(ECOG)Performance Status0,1 6)Measurable lesion meeting RECIST criteria(version1.1) 7)Adequate organ function neutrophil count:>=2,000/mm3or<=13,000/mm3 Platelet count:>=100,000/mm3 Hemoglobin:>=9.5g/dl AST,ALT<=2.5*upper limit of normal Total bilirubin:<=1.5mg/dl creatinine:<=1.5mg/dl PT-INR:<=1.5 Urinary protein negative or 1+ PaO2>=90% 8)Written informed consent
Key exclusion criteria	1)Prior Pemetrexed treatment 2)History of hemoptysis(>=2.5ml) 3)History of severe drug allergy 4)Thrombosis 5)Active infection 6)Any other serious complication (severe heart disease, perforation of the digestive tract, uncontrollable diabetes or hypertension, gastrointestinal hemorrhage, paresis of intestine, illeus, interstinal lung disease etc.) 7)Prior radiotherapy to the chest or the more than 20% region of bone with hematopoietic capacity 8)Massive pleural or pericardial effusion, ascites *include patients if there is no accumulation within two weeks after dranage tube was removed. *exclude patients if pleurosclerosis was performed with anti-cancer drugs except OK-432 9)Inadequate interval after prior treatments *operation including exploratory or diagnostic thoracotomy within 4 weeks *palliative radiotherapy within 2 weeks *biopsy with incision and treatment for trauma (exclude patiente with unhealed wound) within 2 weeks *transfusion or use of hematopoietic factor within 2weeks. 10)Concomitant malignancy 11)Severe psychotic disorder 12)Pregnancy,Lactation,declined contraception 13)Inappropriate for this study judged by the attending physician
Target sample size	45

Research contact person
Name of lead principal investigator	Takeshi Kaneko
Organization	Yokohama City University Medical Center
Division name	Respiratory Disease Center
Address	4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL	045-261-5656
Email	takeshi@med.yokohama-cu.ac.jp

Public contact
Name of contact person	Masaharu Shinkai
Organization	Yokohama City University Medical Center
Division name	Respiratory Disease Center
Address	4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL	045-261-5656
Homepage URL
Email	shinkai@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Medical Center
Institute
Department

Funding Source
Organization	None
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	横浜市立大学附属市民総合医療センター（神奈川県） 大和市立病院（神奈川県） 神奈川県立がんセンター（神奈川県） 藤沢市民病院（神奈川県） 関東労災病院（神奈川県） 横浜南共済病院（神奈川県） 横浜市立大学附属病院（神奈川県） 国立病院機構横浜医療センター（神奈川県） 横浜船員保険病院（神奈川県） 茅ヶ崎市立病院（神奈川県） 横浜栄共済病院（神奈川県） 防衛医科大学校病院（埼玉県）

Other administrative information
Date of disclosure of the study information	2011 Year 11 Month 15 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2011 Year 08 Month 18 Day
Anticipated trial start date	2011 Year 11 Month 01 Day
Last follow-up date	2017 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2011 Year 11 Month 14 Day
Last modified on	2017 Year 01 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007944