UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017777
Receipt number R000020587
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.
Date of disclosure of the study information 2015/06/02
Last modified on 2019/03/07 16:53:59

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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 or person

Institute

University of Tsukuba

Institute

Department

Personal name



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

Value
https://center6.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