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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT01736163
First received: November 26, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Thyroid Cancer
Drug: Thyrogen
Drug: 131I
Other: Thyroid Hormone Withdrawal
Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
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

Resource links provided by NLM:


Further study details as provided by Genzyme, a Sanofi Company:

Primary Outcome Measures:
  • First ablation success rate by Diagnostic Whole Body Scan (DxWBS) [ Time Frame: at least 6 months after administration of first ablation activity of 131I ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • First ablation success rate based on stimulated Thyroglobulin (Tg) levels [ Time Frame: at least 6 months after administration of first ablation activity of 131I ] [ Designated as safety issue: No ]
  • First ablation success rate based on historical records [ Time Frame: at least 6 months after administration of first ablation activity of 131I ] [ Designated as safety issue: No ]
  • Number of adverse events of Thyrogen and 131I arm and THW and 131I arm [ Time Frame: Within 30 days of treatment. ] [ Designated as safety issue: Yes ]
    Exploratory safety assessment in patients with T4 tumour for first ablation of thyroid remnants based on historical records.


Enrollment: 144
Study Start Date: May 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Thyrogen and 131I
Patients were previously treated with Thyrogen in conjunction with a high ablative activity of 131I.
Drug: Thyrogen
0.9 mg IM, administrated for 2 consecutive days
Drug: 131I
28 mCi or ≥ 1.036 GBq.
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
28 mCi or ≥ 1.036 GBq.
Other: Thyroid Hormone Withdrawal
Stop taking hormone therapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01736163

Locations
Germany
Hanover University School of Medicine
Hannover, Germany
Klinikum Großhadern
München, Germany
Italy
Policlinico S.Orsola-Malpighi
Bologna, Italy
Instituto Oncologico Veneto
Padova, Italy
Istituti Fisioterapici Ospitalieri (IFO)
Rome, Italy
Portugal
Portuguese Institute of Oncology
Coimbra, Portugal
Spain
Hospital Universitario Reina Sofía
Cordoba, Spain
Hospital Universitario Virgen de las Nieves
Granada, Spain
Hospital Universitario Dr Peset
Valencia, Spain
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

No publications provided

Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT01736163     History of Changes
Other Study ID Numbers: THYR04910
Study First Received: November 26, 2012
Last Updated: November 26, 2012
Health Authority: European Union: European Medicines Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Thyroid Neoplasms
Thyroid Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014