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

Thyroid Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01736163
• Other study ID #: THYR04910
• Status: Completed
• Phase: Phase 4
• First received: November 26, 2012
• Last updated: March 19, 2015
• Start date: May 2012
• Est. completion date: August 2012

Study information

• Verified date: March 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines AgencyUnited States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Drug:
• Thyrogen
0.9 mg IM, administrated for 2 consecutive days
• 131I
28 mCi or = 1.036 GBq.

Other:
• Thyroid Hormone Withdrawal
Stop taking hormone therapy

Locations

Country	Name	City	State
Germany	Hanover University School of Medicine	Hannover
Germany	Klinikum Großhadern	München
Italy	Policlinico S.Orsola-Malpighi	Bologna
Italy	Instituto Oncologico Veneto	Padova
Italy	Istituti Fisioterapici Ospitalieri (IFO)	Rome
Portugal	Portuguese Institute of Oncology	Coimbra
Spain	Hospital Universitario Reina Sofía	Cordoba
Spain	Hospital Universitario Virgen de las Nieves	Granada
Spain	Hospital Universitario Dr Peset	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Countries where clinical trial is conducted

Germany,  Italy,  Portugal,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First ablation success rate by Diagnostic Whole Body Scan (DxWBS)		at least 6 months after administration of first ablation activity of 131I	No
Secondary	First ablation success rate based on stimulated Thyroglobulin (Tg) levels		at least 6 months after administration of first ablation activity of 131I	No
Secondary	First ablation success rate based on historical records		at least 6 months after administration of first ablation activity of 131I	No
Secondary	Number of adverse events of Thyrogen and 131I arm and THW and 131I arm	Exploratory safety assessment in patients with T4 tumour for first ablation of thyroid remnants based on historical records.	Within 30 days of treatment.	Yes