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
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
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
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
