A Retrospective Observational Study Comparing Two Different Treatment Options in Thyroid Cancer Patients With T4 Tumours
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01736163|
Recruitment Status : Completed
First Posted : November 29, 2012
Last Update Posted : March 23, 2015
|Condition or disease||Intervention/treatment|
|Thyroid Cancer||Drug: Thyrogen Drug: 131I Other: Thyroid Hormone Withdrawal|
|Study Type :||Observational|
|Actual Enrollment :||144 participants|
|Official Title:||A Retrospective, Non-interventional Study of Patients With T4 Tumours Comparing the Thyroid Remnant Ablation Success Following Thyrogen and 131I Administration Versus Thyroid Hormone Withdrawal and 131I Administration|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||August 2012|
Thyrogen and 131I
Patients were previously treated with Thyrogen in conjunction with a high ablative activity of 131I.
0.9 mg IM, administrated for 2 consecutive days
28 mCi or ≥ 1.036 GBq.
Thyroid Hormone Withdrawal and 131I
Patients were previously treated with Thyroid hormone withdrawal (THW) in conjunction with a high ablative activity of 131I.
28 mCi or ≥ 1.036 GBq.
Other: Thyroid Hormone Withdrawal
Stop taking hormone therapy
- First ablation success rate by Diagnostic Whole Body Scan (DxWBS) [ Time Frame: at least 6 months after administration of first ablation activity of 131I ]
- First ablation success rate based on stimulated Thyroglobulin (Tg) levels [ Time Frame: at least 6 months after administration of first ablation activity of 131I ]
- First ablation success rate based on historical records [ Time Frame: at least 6 months after administration of first ablation activity of 131I ]
- Number of adverse events of Thyrogen and 131I arm and THW and 131I arm [ Time Frame: Within 30 days of treatment. ]Exploratory safety assessment in patients with T4 tumour for first ablation of thyroid remnants based on historical records.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01736163
|Hanover University School of Medicine|
|Instituto Oncologico Veneto|
|Istituti Fisioterapici Ospitalieri (IFO)|
|Portuguese Institute of Oncology|
|Hospital Universitario Reina Sofía|
|Hospital Universitario Virgen de las Nieves|
|Hospital Universitario Dr Peset|
|Study Director:||Medical Monitor||Genzyme, a Sanofi Company|