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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000017777 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | Thyroid cancer | |
Classification by specialty |
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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 |
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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 | ||
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Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 47 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
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Management information | |||||||
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Last modified on |
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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 |