UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A prospective study of efficacy and safety of lenvatinib in patients with RAI-refractory differentiated thyroid cancer patients
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	YAMASHITA Hideomi
Organization	The University of Tokyo Hospital
Division name	Department of Radiology
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL	+81-3-5800-8667
Email	yamachan07291973@yahoo.co.jp

Public contact
Name of contact person	AOKI Shuri
Organization	The University of Tokyo Hospital
Division name	Department of Radiology
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 03 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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-bin/ctr_e/ctr_view.cgi?recptno=R000025087