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

Completed

• Conditions: Thyroid Cancer
• Interventions: Drug: Thyrogen; Drug: 131I; Other: Thyroid Hormone Withdrawal

• Registration Number: NCT01736163
• Lead Sponsor: Genzyme, a Sanofi Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Study First Submitted: 2012-11-26
• Study First Submitted QC: 2012-11-26
• Study First Posted: 2012-11-29
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-19
• Last Update Posted: 2015-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Thyrogen and 131I	131I	Patients were previously treated with Thyrogen in conjunction with a high ablative activity of 131I.
Thyroid Hormone Withdrawal and 131I	131I	Patients were previously treated with Thyroid hormone withdrawal (THW) in conjunction with a high ablative activity of 131I.
Thyroid Hormone Withdrawal and 131I	Thyroid Hormone Withdrawal	Patients were previously treated with Thyroid hormone withdrawal (THW) in conjunction with a high ablative activity of 131I.
Thyrogen and 131I	Thyrogen	Patients were previously treated with Thyrogen in conjunction with a high ablative activity of 131I.

Primary Outcome Measures

Name	Time	Method
First ablation success rate by Diagnostic Whole Body Scan (DxWBS)	at least 6 months after administration of first ablation activity of 131I

Secondary Outcome Measures

Name	Time	Method
First ablation success rate based on stimulated Thyroglobulin (Tg) levels	at least 6 months after administration of first ablation activity of 131I
First ablation success rate based on historical records	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	Within 30 days of treatment.	Exploratory safety assessment in patients with T4 tumour for first ablation of thyroid remnants based on historical records.

Trial Locations

Locations (9)

Portuguese Institute of Oncology; 🇵🇹 Coimbra, Portugal

Policlinico S.Orsola-Malpighi; 🇮🇹 Bologna, Italy

Klinikum Großhadern; 🇩🇪 München, Germany

Instituto Oncologico Veneto; 🇮🇹 Padova, Italy

Hanover University School of Medicine; 🇩🇪 Hannover, Germany

Istituti Fisioterapici Ospitalieri (IFO); 🇮🇹 Rome, Italy

Hospital Universitario Reina Sofía; 🇪🇸 Cordoba, Spain

Hospital Universitario Virgen de las Nieves; 🇪🇸 Granada, Spain

Hospital Universitario Dr Peset; 🇪🇸 Valencia, Spain