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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000021757
Receipt No. R000025087
Scientific Title A prospective study of efficacy and safety of lenvatinib in patients with RAI-refractory differentiated thyroid cancer patients
Date of disclosure of the study information 2016/04/03
Last modified on 2016/04/03

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Basic information
Public title A prospective study of efficacy and safety of lenvatinib in patients with RAI-refractory differentiated thyroid cancer patients
Acronym Liberty-study
(Efficacy and benefit of lenvatinib after resistance to I-131 treatment for differentiated thyroid cancer)
Scientific Title A prospective study of efficacy and safety of lenvatinib in patients with RAI-refractory differentiated thyroid cancer patients
Scientific Title:Acronym Liberty-study
(Efficacy and benefit of lenvatinib after resistance to I-131 treatment for differentiated thyroid cancer)
Region
Japan

Condition
Condition thyroid cancer
Classification by specialty
Endocrinology and Metabolism Endocrine surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the validity of early administration of lenvatinib in patients with RAI-refractory differentiated thyroid cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes progression-free survival
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Daily 20mg of lenvatinib is orally administered until tumor progression or the onset of untolerable adverse events.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with I-131-resistant differentiated thyroid cancer
a) unresectable
b) pathologically proven PTC or FTC
c) measurable lesions acccording to RECIST1.1 criteria
d) RAI-resistance
e) no (or controled) brain metastases
f) controled blood pressure
g) Patients with sufficient organ function
h) low THS
i) Performance status (ECOG) of 0-2
j) Written informed concent
Key exclusion criteria a) undifferentiated and medullary carcinoma
b) prior therapy with lenvatinib
c) preteninuria
d) with severe heart failure
e) bleeding/atherothrombotic disorder, or use of anticoagulants
f) with another active malignant tumors
g) pregnant and/or lactating women
h) judged to be unfit to this study by investigater
Target sample size 320

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name YAMASHITA Hideomi
Organization The University of Tokyo Hospital
Division name Department of Radiology
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL +81-3-5800-8667
Email yamachan07291973@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name AOKI Shuri
Organization The University of Tokyo Hospital
Division name Department of Radiology
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL +81-3-5800-8667
Homepage URL
Email daisy.shuri@gmail.com

Sponsor
Institute The University of Tokyo Hospital
Institute
Department

Funding Source
Organization non
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
2016 Year 04 Month 03 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 Enrolling by invitation
Date of protocol fixation
2016 Year 03 Month 24 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 04 Month 03 Day
Last modified on
2016 Year 04 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025087

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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