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

NCT01736163 | Completed

• 1 other identifier: THYR04910
• Study Type: observational
• Target: 144
• Locations: 4 countries
• Sites: 9

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.

Conditions

Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

• First ablation success rate by Diagnostic Whole Body Scan (DxWBS)

  at least 6 months after administration of first ablation activity of 131I

Secondary Outcomes (3)

• 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.

Study Arms (2)

Thyrogen and 131I

Patients were previously treated with Thyrogen in conjunction with a high ablative activity of 131I.

Drug: Thyrogen; Drug: 131I

Thyroid Hormone Withdrawal and 131I

Patients were previously treated with Thyroid hormone withdrawal (THW) in conjunction with a high ablative activity of 131I.

Drug: 131I; Other: Thyroid Hormone Withdrawal

Interventions

Thyrogen DRUG

0.9 mg IM, administrated for 2 consecutive days

Thyrogen and 131I

131I DRUG

28 mCi or ≥ 1.036 GBq.

Thyrogen and 131I; Thyroid Hormone Withdrawal and 131I

Thyroid Hormone Withdrawal OTHER

Stop taking hormone therapy

Thyroid Hormone Withdrawal and 131I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Historical records at clinical sites will be reviewed in a systematic fashion to identify eligible patients.

You may qualify if:

• Male or female patients living or deceased, aged 18 years or older at the time of first ablation for thyroid cancer.
• 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.
• Undergone a near-total or total thyroidectomy on or after 01 January 2000
• Undergone first ablation of thyroid remnants with high activity 131I (≥28 mCi or ≥ 1.036 GBq).
• 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).
• 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.

You may not qualify if:

• Historical records from patients who meet any of the following criteria will be excluded from this retrospective evaluation:
• 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.
• Received any iodine-containing contrast agents within 3 months prior to first ablative activity of 131I administered.
• Used amiodarone within the 2 years prior to first ablative activity of 131I administered.

Sponsors & Collaborators

• Genzyme, a Sanofi Company: lead

Study Sites (9)

Hanover University School of Medicine

Hanover, Germany

Location

Klinikum Großhadern

München, Germany

Location

Policlinico S.Orsola-Malpighi

Bologna, Italy

Location

Instituto Oncologico Veneto

Padua, Italy

Location

Istituti Fisioterapici Ospitalieri (IFO)

Rome, Italy

Location

Portuguese Institute of Oncology

Coimbra, Portugal

Location

Hospital Universitario Reina Sofía

Córdoba, Spain

Location

Hospital Universitario Virgen de las Nieves

Granada, Spain

Location

Hospital Universitario Dr Peset

Valencia, Spain

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Thyrotropin Alfa

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Thyrotropin; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Medical Monitor

  Genzyme, a Sanofi Company

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2012
• First Posted: November 29, 2012
• Study Start: May 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: March 23, 2015

Record last verified: 2015-03

Locations

IT (3); PT (1); DE (2); ES (3)