UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021757 |
|---|---|
| Receipt number | 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 12:53:12 |
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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
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
daisy.shuri@gmail.com
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025087
