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A Retrospective Observational Study Comparing Two Different Treatment Options in Thyroid Cancer Patients With T4 Tumours

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Thyroid Cancer

Intervention: Thyrogen (Drug); 131I (Drug); Thyroid Hormone Withdrawal (Other)

Phase: Phase 4

Status: Completed

Sponsored by: Genzyme, a Sanofi Company

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Genzyme, a Sanofi Company


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.

Clinical Details

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 design: Observational Model: Case Control, Time Perspective: Retrospective

Primary outcome: First ablation success rate by Diagnostic Whole Body Scan (DxWBS)

Secondary outcome:

First ablation success rate based on stimulated Thyroglobulin (Tg) levels

First ablation success rate based on historical records

Number of adverse events of Thyrogen and 131I arm and THW and 131I arm


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria: Historical records from patients who meet all of the following criteria will be eligible for inclusion in this retrospective evaluation: 1. Male or female patients living or deceased, aged 18 years or older at the time of first ablation for thyroid cancer. 2. Diagnosed with a well-differentiated T4 tumour (defined as a primary tumour of any size that extends beyond the thyroid capsule [this may be referred to as TNM classification T4, N0-1, M0-1]). This excludes unusual histological types such as oncocytic (Hurthle cell carcinoma), tall cell, sclerosing or cribriform thyroid cancers. 3. Undergone a near-total or total thyroidectomy on or after 01 January 2000 4. Undergone first ablation of thyroid remnants with high activity 131I (≥28 mCi or ≥ 1. 036 GBq). 5. Undergone first 131I ablation for the T4 tumour using either Thyrogen (0. 9 mg IM on 2 consecutive days) or THW stimulation. This excludes use of non-standard Thyrogen regimens (i. e., had a regimen of Thyrogen other than the standard 0. 9 mg IM on 2 consecutive days or received Thyrogen in combination with THW). 6. Historical records are available confirming ablation results by:

- DxWBS using small activity (≥2 mCi or 74 MBq) of iodine 131I (or 123I) performed

at least 6 months after administration of the first ablation activity of 131I and/or

- Stimulated Tg measured at least 6 months after administration of the first

ablation activity of 131I. Exclusion Criteria: Historical records from patients who meet any of the following criteria will be excluded from this retrospective evaluation: 1. Received propylthiouracil, methimazole, vitamins or supplements containing kelp or iodine (taking a multivitamin that does not contain iodine or kelp is acceptable), medications that significantly affect iodine handling such as high dose corticosteroids, high dose diuretics, or lithium in the 45 days before administration of first ablative activity of 131I. 2. Received any iodine-containing contrast agents within 3 months prior to first ablative activity of 131I administered. 3. Used amiodarone within the 2 years prior to first ablative activity of 131I administered.

Locations and Contacts

Hanover University School of Medicine, Hannover, Germany

Klinikum Großhadern, München, Germany

Policlinico S.Orsola-Malpighi, Bologna, Italy

Instituto Oncologico Veneto, Padova, Italy

Istituti Fisioterapici Ospitalieri (IFO), Rome, Italy

Portuguese Institute of Oncology, Coimbra, Portugal

Hospital Universitario Reina Sofía, Cordoba, Spain

Hospital Universitario Virgen de las Nieves, Granada, Spain

Hospital Universitario Dr Peset, Valencia, Spain

Additional Information

Starting date: May 2012
Last updated: March 19, 2015

Page last updated: August 23, 2015

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