UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of continuation maintenance by use of TS1 and Bevacizumab after induction chemotherapy of cisplatin and TS1 pulse bevacizumab in patients with Stage IIIB / IV non-squamous and non-small cell lung cancer - Research of efficacy predictive biomarker
Title of the study (Brief title)	Phase II of cisplatin and TS1 pulse bevacizumab followed by TS1 and bevacizumab
Region	Japan

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

Objectives
Narrative objectives1	To evaluate efficacy and safety of cisplatin and TS1 pulse bevacizumab followed by TS1 and bevacizumab in patients with Stage IIIB / IV non-squamous and non-small cell lung cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	Progression free survival from the beginning of maintenance therapy
Key secondary outcomes	Response rate by RECIST, Overall survival, Time to treatment failure, Adverse events, Quality of life, Efficacy predictive factors (Thymidylate synthase, Dihydoropyrimidine dehydrogenase, others)

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	Cisplatin and TS1 pulse bevacizumab followed by TS1 and bevacizumab the other trial of same chemotherapy without bevacizumab at same time
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	I) Eligibility criteria for Pre-registration 1) Histologically or cytologically proven non-squamous and non-small cell lung cancer 2) Stage IIIB/IV without indication for radical thoracic irradiation or recurrence after surgical treatment 3) Naive treatment of cytotoxic chemotherapy. Treatments below are acceptable for pre-registaration a) Palliative Irradiation except primary tumor of lung more than 2 weeks ago b)First line treatment by epidermal growth factor receptor-tyrosine kinase inhibitors more than 2 weeks ago c)post-operation adjuvant therapy more than 6 months. 4)Eastern Cooperative Oncology Group performance status of 0-1 5)Age; > or = 20 years and < 75 years 6) Tumor has the evaluable lesion. 7) capable of oral intake 8) Adequate organ function, Adequate organ function within 2 weeks a) Leukocyte count; > or = 3,000/mm3 b) Neutrophil count; > or = 1,500/mm3 c) Platelet count; > or = 100,000/mm3 d) Hemoglobin concentration; > or = 10.0g/dl e) Total bilirubin level; < or = 2.0 mg/dl f) Aspartate aminotransferse and alanine aminotransferase levels; < or = 100 IU/L g) PaO2; > or = 60 Torr or SpO2; > or = 90% at room air h) Creatinine clearance; > or = 60mL/min 9) Estimating Survival more than 12 weeks 10)Written informed consent II) Eligibility Criteria for registration 1) More than 2 cycles of induction chemotherapy 2) Response criteria of induction chemotherapy achieved more than and equal to SD. 3) Maintenance can start within 6 weeks after start of TS1 of last cycle.
Key exclusion criteria	1) Patients with squamous cell lung cancer. 2) History of allergic reaction for agents of present treatment 3) Severe myelosupperssion, renal dysfunction or hepatic dysfunction 4) Patients received post-operation adjuvant therapy within 6 months. 5) Active concomitant malignancy except carcinoma in situ, intramucosal carcinoma or cancer with more than 5 year disease free 6) Significant comorbid disease such as paresis of intestine, ileus, interstitial pneumonia, lung fibrosis, uncontrolled diabetes mellitus, cardiac failure, renal failure, hepatic failure, active gastrointestinal ulcer, myocardial infarction and angina pectoris within 6 months, other uncontrolled disease 7) Diarrhea more than and equal to grade 2 8) Active infection more than and equal to grade 2 9) Massive pleural effusion, peritoneal effusion or cardiac effusion required for tube drainage 10) Symptomatic brain metastasis but eligible for controlled brain metastases 11) Patients required for continuing steroid therapy 12) A history of significant hemoptysis (> 2.5 mL red blood per episode) within 3 months before enrolment 13) History of thrombosis 14) Surgical biopsy or treatment within 4 weeks 15) Under treatment of oral coagulant or intravenous coagulant 16) Bleeding tendency, blood coagulation disorder 17) Other ineligible for bevacizumab 18) Pregnant status or lactation 19) Uncontrolled psychiatric disease 20) Other ineligible status judged by medical oncologist.
Target sample size	33

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, 162-8655, 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, 162-8655, Japan
TEL	03-3202-7181
Homepage URL
Email	ytakeda@hosp.ncgm.go.jp

Sponsor
Institute	Department of Respiratory Medicine National Center for Global health and Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	None

Other related organizations
Co-sponsor	None
Name of secondary funｄer(s)	None

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	国立国際医療研究センター病院（東京都）

Other administrative information
Date of disclosure of the study information	2013 Year 01 Month 31 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 10 Month 17 Day
Anticipated trial start date	2012 Year 12 Month 17 Day
Last follow-up date	2018 Year 12 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	2013 Year 01 Month 25 Day
Last modified on	2018 Year 09 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011567