Clinical trial NCT01736163: A Retrospective Observational Study Comparing Two Different Treatment Options in Thyroid Cancer Patients With T4 Tumours
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thyroid Cancer
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2012-11-29
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Historical records at clinical sites will be reviewed in a systematic fashion to identify eligible patients.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: First ablation success rate by Diagnostic Whole Body Scan (DxWBS)
timeFrame: at least 6 months after administration of first ablation activity of 131I
Secondary outcomes:
measure: First ablation success rate based on stimulated Thyroglobulin (Tg) levels
timeFrame: at least 6 months after administration of first ablation activity of 131I
measure: First ablation success rate based on historical records
timeFrame: at least 6 months after administration of first ablation activity of 131I
measure: Number of adverse events of Thyrogen and 131I arm and THW and 131I arm
timeFrame: Within 30 days of treatment.
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hanover University School of Medicine
city: München
country: Germany
facility: Klinikum Großhadern
city: Bologna
country: Italy
facility: Policlinico S.Orsola-Malpighi
city: Padova
country: Italy
facility: Instituto Oncologico Veneto
city: Rome
country: Italy
facility: Istituti Fisioterapici Ospitalieri (IFO)
city: Coimbra
country: Portugal
facility: Portuguese Institute of Oncology
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Valencia
country: Spain
facility: Hospital Universitario Dr Peset
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References: