UMIN-CTR Clinical Trial

Basic information
Public title	The study evaluating the efficacy and safety of sorafenib in patients with differentiated thyroid cancer not amendable to radioactive iodine therapy and other alternative treatment.
Acronym	RAI-skip
Scientific Title	The study evaluating the efficacy and safety of sorafenib in patients with differentiated thyroid cancer not amendable to radioactive iodine therapy and other alternative treatment.
Scientific Title:Acronym	RAI-skip
Region	Japan

Condition
Condition	Thyroid cancer
Classification by specialty	Endocrine surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy and safety of sorafenib in patients with differentiated thyroid cancer not amenable to radioactive iodine therapy (RAI) (i.e., RAI therapy naive and difficult to treat with RAI)
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	Response rate
Key secondary outcomes	1. Progression-free survival 2. Disease control rate 3. Tumor growth rate 4. Overall survival 5. Adverse event 6. QOL (EQ5D, EQ-VAS)

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	Oral administration of 400 mg sorafenib (200mg tablet x 2) b.i.d.
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. Patients must be able to understand and willing to sign a written informed consent 2. Age >=20 3. Patients with RAI unsuitable (i.e., RAI therapy naive and difficult to treat with RAI) 4. Not a candidate for surgery or radiotherapy with curative intent 5. Locally advanced or metastatic differentiated thyroid cancer (papillary, follicular and Hurthle cell), poorly differentiated and other thyroid variants provided that the histology has no medullary differentiation nor anaplastic features 6. Progression within 14 months (RECIST should be used as a basis for the assessment of disease progression) prior to enrollment 7. Patients with at least one measurable lesion. Lesions must be measured by CT or MRI according to RECIST v1.1 8. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements prior to enrollment: 1) Hemoglobin: > 9.0 g/dL 2) Absolute neutrophil count (ANC): > 1,500/mm3 3) Platelet count: > 100,000/mm3 4) Total bilirubin: 1.5 times the upper limit of normal (ULN) 5) ALT and AST: < 2.5 x ULN 6) PT/PT-INR and PTT: < 1.5 x ULN 7) Serum creatinine: < 1.5 x ULN 9. Patients must be able to swallow and retain oral medication 10. ECOG performance status (PS) of 0, 1 or 2 (Patients with walking difficulty caused by bone metastases are eligible regardless of PS) 11. Life expectancy of at least 12 weeks
Key exclusion criteria	1. Histologic subtypes of thyroid cancer other than differentiated (i.e., anaplastic and medullary cancer, lymphoma or sarcoma) 2. Prior anti-cancer treatment with tyrosine kinase inhibitors, monoclonal antibodies that target VEGF or VEGF receptors or other target agents 3. Prior anti-cancer treatment for thyroid cancer with use of chemotherapy, Thalidomide or any of its derivatives 4. Use of biologic response modifiers, such as G-CSF, within 21 days of enrollment 5. Non-healing wound, ulcer, or bone fracture 6. Evidence or history of bleeding diathesis or coagulopathy disorder 7. Metastatic brain with symptom or requiring medication 8. Tracheal, bronchial or esophageal infiltration with significant risk of bleeding not treated locally prior to enrollment 9. Clinically significant cardiac disease including congestive heart failure, unstable angina, new-onset angina or myocardial infraction within the past 6 months prior to enrollment 10. Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy or uncontrolled hypertension (systolic blood pressure >150 mmHg or diastolic pressure > 90 mmHg) despite optimal medical management 11. Thrombotic or embolic venous or arterial events within the past 6 months 12. Hemorrhage/bleeding event, >=Grade 3 according to NCI-CTCAE within 3 months of enrollment 13. Infection >= NCI-CTCAE Grade 3 14. Known HIV infection or infection with hepatitis B or C virus 15. Previous or concurrent active cancer affecting prognosis that is distinct in primary site or histology from thyroid cancer 16. Pregnant or breast-feeding women 17. Women and men desiring to get pregnant or bear children during the study period or within 30 days after the end of this study 18. Seizure disorder requiring medication 19. Having Renal dialysis 20. Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
Target sample size	47

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hisato Hara
Organization	University of Tsukuba
Division name	Faculty of Medicine
Zip code
Address	1-1-1 Tennodai, Tsukuba, Ibarakii, Japan
TEL	029-853-3341
Email	harahisa@md.tsukuba.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hisato Hara
Organization	University of Tsukuba
Division name	Faculty of Medicine
Zip code
Address	1-1-1 Tennodai, Tsukuba, Ibarakii, Japan
TEL	029-853-3341
Homepage URL
Email	harahisa@md.tsukuba.ac.jp

Sponsor
Institute	University of Tsukuba
Institute
Department

Funding Source
Organization	Bayer Yakuhin Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Tsukuba Clinical Research & Development Organization
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	筑波大学附属病院（茨城県）、他

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 02 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	Completed
Date of protocol fixation	2015 Year 06 Month 02 Day
Date of IRB
Anticipated trial start date	2015 Year 09 Month 01 Day
Last follow-up date	2018 Year 09 Month 30 Day
Date of closure to data entry	2018 Year 11 Month 27 Day
Date trial data considered complete	2019 Year 02 Month 19 Day
Date analysis concluded	2019 Year 03 Month 07 Day

Other
Other related information

Management information
Registered date	2015 Year 06 Month 02 Day
Last modified on	2019 Year 03 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020587

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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