UMIN-CTR Clinical Trial

Basic information
Public title	A Phase II Study of Bevacizumab (Avastin®) in Combination with Standard Second line chemotherapy (Docetaxel Or Pemetrexed) in Patients with Non-Squamous Non-Small-Cell Lung Cancer previously Treated with chemotherapy
Acronym	ADOPT study
Scientific Title	A Phase II Study of Bevacizumab (Avastin®) in Combination with Standard Second line chemotherapy (Docetaxel Or Pemetrexed) in Patients with Non-Squamous Non-Small-Cell Lung Cancer previously Treated with chemotherapy
Scientific Title:Acronym	ADOPT study
Region	Japan

Condition
Condition	Non-sq NSCLC with previously treated
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of Bevacizumab in combination with Docetaxel or Pemetrexed for patients previously treated with combining chemotherapy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	progression free survival
Key secondary outcomes	disease control rate,overall survival, and safety

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	Bevasizumab + Pemetrexed
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) Pathologically or cytplogically confirmed non-small cell lung cancer. Patients with clinical stage IIIB/IV or postoperative recurrence, and unsuitable for radiotherapy. (2) Previously treated (3) Patients who has measurable by RECIST(ver 1.1)criteria. (4) performance status of 0-2 (5) Age of 20 years or older (6) Adequate organ functions (7) Life expectancy more than 90 days (8) Written informed consent
Key exclusion criteria	(1) Previously untreated with platinum doublet (2) transfusion or G-CSF within 2weeks prior to enrollment (3) Severe renal function disorder, 2+ or higher proteinuria within 2 weeks prior to enrollment (4) History of severe drug allergy (5) History of active double cancer within 5 years (6) History of active severe infections (7) Patients who have fever of over 38 degrees (8) Continuous administration of steroid drug (9) severe cardiac disease (10) History of thromboembolism or severe pulmonary disease (11) History of GI bleeding , ileus, GI ulceration (12) massive pleural or pericardial effusion, ascites (13) Symptomatic brain metastases (14) Uncontrollable hypertension or diabetes mellitus (15) Uncontrollable diarrhea (16) Wound of unrecovery (17) Traumatic fracture of unrecovery (18) bleeding diathesis or receiving anticoagulant drug(except Aspirin under 324mg/day) (19) History of pregnancy or lactation (20) Evaluated to be ineligible by a physician for other reasons
Target sample size	34

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Kazunori Fujitaka
Organization	Hiroshima University Hospital
Division name	Respiratory medicine
Zip code
Address	1-2-3 kasumi , minami-ku, Hiroshima, 734-8551, Japan
TEL
Email

Public contact
1st name of contact person	1st name Middle name Last name Kazunori Fujitaka
Organization	Hiroshima University Hospital
Division name	Respiratory medicine
Zip code
Address
TEL	81-082-257-5195
Homepage URL
Email

Sponsor
Institute	Hiroshima University Hospital Respiratory medicine
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)

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 02 Month 01 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	Terminated
Date of protocol fixation	2012 Year 02 Month 01 Day
Date of IRB	2012 Year 07 Month 25 Day
Anticipated trial start date	2012 Year 02 Month 01 Day
Last follow-up date	2018 Year 01 Month 05 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 01 Month 23 Day
Last modified on	2019 Year 04 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008389