Sorafenib as Adjuvant to Radioiodine Therapy in Non-Medullary Thyroid Carcinoma
|First Received Date ICMJE||April 22, 2009|
|Last Updated Date||April 22, 2009|
|Start Date ICMJE||October 2007|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Proportion of patients with a favorable response to Sorafenib defined as ONE OR MORE of the following criteria: 1. Reinduction of RaI uptake by RaI scintigraphy. 2. Serum thyroglobulin levels. 3. RECIST criteria [ Time Frame: 6 months ] [ Designated as safety issue: No ]|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||No Changes Posted|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Sorafenib as Adjuvant to Radioiodine Therapy in Non-Medullary Thyroid Carcinoma|
|Official Title ICMJE||Sorafenib as Adjuvant to Radioiodine Therapy in Non-Medullary Thyroid Carcinoma|
The purpose of this study is to assess whether therapy with Sorafenib reinduces radioiodine uptake in thyroid carcinoma.
Background of the study:
Therapy with radioiodine (RaI) is the only curative therapy in non-medullary thyroid carcinoma. RaI uptake is frequently lost in this disease. Therapy with tyrosine kinase inhibitors may restore the susceptibility to RaI.
Objective of the study:
To investigate whether therapy with the tyrosine kinase inhibitor Sorafenib will increase the accumulation of radioiodine (RaI) and decrease tumor progression in patients with recurrences or metastases of non-medullary thyroid carcinoma with absent or insufficient accumulation of RaI.
Prospective, open study with patients with recurrences or metastases of differentiated thyroid carcinoma who will undergo 6 months therapy with Sorafenib 800 mg/day. Patients in whom RaI uptake will be restored will be offered high dose (6000 MBq) RaI together with an additional 6 months treatment with Sorafenib. Patients in whom RaI is not be restored but in whom Sorafenib had a favorable effect on tumor growth will be offered continued treatment with Sorafenib.
Thirty patients will be included with recurrences or metastases of differentiated thyroid carcinoma that are unresponsive to RaI therapy.
Intervention (if applicable):
After inclusion, patients will undergo 131I scintigraphy as well as a CT scan. Thereafter, therapy with Sorafenib 800 mg/day will be initiated, and continued during 6 months. After 6 months, 131I scintigraphy and CT scans will be repeated. Serum levels of thyroglobulin will be used as tumormarker.
Primary study parameters/outcome of the study:
The endpoint of the study is the proportion of patients with a favorable response to Sorafenib defined as ONE OR MORE of the following criteria:
The absence of progression according to RECIST criteria:
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Condition ICMJE||Thyroid Cancer|
|Intervention ICMJE||Drug: Sorafenib (nexavar)
6 months therapy with Sorafenib 800 mg/day
Other Name: nexavar
|Study Arm (s)||Experimental: sorafenib
30 patients with non-radioiodine avid differentiated thyroid carcinoma
Intervention: Drug: Sorafenib (nexavar)
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 80 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Netherlands|
|NCT Number ICMJE||NCT00887107|
|Other Study ID Numbers ICMJE||NL17727.058.07, P07.109|
|Has Data Monitoring Committee||No|
|Responsible Party||Johannes Smit, M.D., Ph.D., leiden University Medical Center|
|Study Sponsor ICMJE||Leiden University Medical Center|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Leiden University Medical Center|
|Verification Date||April 2009|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP