A Retrospective Observational Study Comparing Two Different Treatment Options in Thyroid Cancer Patients With T4 Tumours
The study is to demonstrate non-inferior thyroid remnant first ablation success of Thyrogen and 131I compared to thyroid hormone withdrawal (THW) and 131I in patients with T4 tumour based on historical diagnostic whole body scan (DxWBS) records.
Other: Thyroid Hormone Withdrawal
|Study Design:||Observational Model: Case Control
Time Perspective: Retrospective
|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|
- First ablation success rate by Diagnostic Whole Body Scan (DxWBS) [ Time Frame: at least 6 months after administration of first ablation activity of 131I ] [ Designated as safety issue: No ]
- First ablation success rate based on stimulated Thyroglobulin (Tg) levels [ Time Frame: at least 6 months after administration of first ablation activity of 131I ] [ Designated as safety issue: No ]
- First ablation success rate based on historical records [ Time Frame: at least 6 months after administration of first ablation activity of 131I ] [ Designated as safety issue: No ]
- Number of adverse events of Thyrogen and 131I arm and THW and 131I arm [ Time Frame: Within 30 days of treatment. ] [ Designated as safety issue: Yes ]Exploratory safety assessment in patients with T4 tumour for first ablation of thyroid remnants based on historical records.
|Study Start Date:||May 2012|
|Study Completion Date:||August 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
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 daysDrug: 131I
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
Please refer to this study by its ClinicalTrials.gov identifier: 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|