UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Bevacizumab (Avastin) therapy in combination with carboplatin and weekly paclitaxel for advanced non-squamous non-small cell lung cancer
Title of the study (Brief title)	Bevacizumab (Avastin) therapy in combination with carboplatin and weekly paclitaxel for advanced non-squamous non-small cell lung cancer
Region	Japan

Condition
Condition	Non-squamous Non-small-cell Lung Cancer
Classification by specialty	Pneumology Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Investigation of efficacy and safety of bevacizumab in combination with carboplatin and weekly paclitaxel for patients with advanced non-squamous non-small cell lung cancer who are not treated 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	Safety, Progression free survival, Time to response, Response duration, Overall survival

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	Patients receive paclitaxel on days 1, 8, and 15 and carboplatin [area under the curve (AUC) = 6] on day 1 and Bevacizumab(15mg/kg,i.v.) on day1, every four weeks, up to six cycles. Patients who still control disease without unacceptable toxicity, then continuously treated with Bevacizumab(15mg/kg,i.v.) on Day1, every three weeks, until disease progression.
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	74 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Written informed consent (2) Age: 20-74 years old (3)ECOG performance status of 0 or 1 (4) Life expectancy more than 3 months (5)histologically or cytologically confirmed non-squamous non-small cell lung cancer(NSCLC) (6)StageIV or postoperative recurrence non-squamous non-small cell lung cancer (7)cheno-naive patient (8)Measurable by RECST(ver 1.1) criteria. (9) If the patient underwent therapy, there should be the following interval between the therapy and the registration 1)immunotherapy and endcrintherapy ->3 weeks 2)Radiotherapy other than thoracic radiation ->2 week 3)Surgery ->4 weeks 4)Thoracic drainarge ->2 weeks 5)Open biopsy, treatment of injury ->2 weeks 6) Transfusion and growth factor ->2 weeks 7)Aspiration biopsy, CV-port reservation ->1 week (10) Adequate organ function
Key exclusion criteria	(1) brain metastasis (2) active concomitant malignancy (3) Current or previous history of hemoptysis or active hemosputum (4) evidence of bleeding diathesis or coagulopathy (5) Current or previous history of Pericardial effusion (6) superior vena cava syndrome (7) spinal cord compression (8) Current or previous (within the last 1 year) history of cerebrovascular disease (9) Traumatic fracture of unrecovery (10) History of active infection (11) The operation has been scheduled for the examination period (12) receiving anticoagulant drug(except Aspirin under 324mg/day) (13) Uncontrollable Gastrointestinal ulceration (14) Current or previous (within the last 1 year) history of GI perforation (15) Uncontrollable hypertension (16) severe cardiac disease (17)Interstitial pneumonia or pulmonary fibrosis detectable on CT scan or X-ray (18)peripheral neuropathy > Grade2 (19) severe drug allergy (20) history of hypersensitivity of Taxans or alcohol and the medicine made of the polio castor oil content (21) treatment history of bevacizumab (22) History of pregnancy or lactation (23) No intention to practice birth control (24) those judged to be not suitable by the attending physician
Target sample size	33

Research contact person
Name of lead principal investigator	Masahiro Yamasaki
Organization	Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
Division name	Department of Respiratory Medicine
Address	1-9-6 Senda-machi Nakaku hirosihima-city 730-8619 Japan
TEL	082-241-3111
Email

Public contact
Name of contact person	Soumuka
Organization	Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
Division name	Department of Respiratory Medicine
Address	1-9-6 Senda-machi Nakaku Hiroshima-city 730-8619 Japan
TEL	082-241-3111
Homepage URL
Email	soumu@hiroshima-med.jrc.or.jp

Sponsor
Institute	Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
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

Other administrative information
Date of disclosure of the study information	2010 Year 05 Month 05 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2010 Year 05 Month 15 Day
Anticipated trial start date	2010 Year 06 Month 02 Day
Last follow-up date	2015 Year 12 Month 31 Day
Date of closure to data entry	2015 Year 12 Month 31 Day
Date trial data considered complete	2015 Year 12 Month 31 Day
Date analysis concluded	2016 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://ar.iiarjournals.org/content/37/2/923.full
Results	The overall response rate was 76%. The median progression free survival and overall survival were 8.4 months and 22.2 months, respectively. Grade 3-4 toxicities included neutropenia in 55% of patients, anemia in 18%, febrile neutropenia in 12%, and anorexia in 9%. No treatment-related deaths were observed.
Other related information

Management information
Registered date	2010 Year 05 Month 05 Day
Last modified on	2017 Year 05 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000004263