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Medico-Economic Comparison of Four Strategies of Radioiodine Ablation in Thyroid Carcinoma Patients (Estimabl)

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ClinicalTrials.gov Identifier: NCT00435851
Recruitment Status : Unknown
Verified February 2007 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was:  Not yet recruiting
First Posted : February 16, 2007
Last Update Posted : February 19, 2007
Sponsor:
Collaborator:
National Cancer Institute, France
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris

Brief Summary:

In France, 3,700 new cases of thyroid cancer are diagnosed each year. Differentiated thyroid carcinoma represents more than 90% of all thyroid cancers; and has a 10-year survival of 90-95% of patients. This favorable prognosis is the result of an effective primary therapy, which consists of a total thyroidectomy that is followed by radio-iodine ablation with 3,7GBq (100mCi) in case of significant risk of persistent disease. Few centers investigated the possibility to administer lower doses of 131I (1GBq, 30 mCi), in order to limit the potential long-term adverse complications for patients and to respond to radioprotection rules for family members and medical staff.

Radio-iodine ablation requires TSH stimulation, which was historically achieved by thyroid hormone withdrawal for 3 to 5 weeks. During this period, patients suffered from symptoms of hypothyroidism. The recombinant human TSH (rhTSH, Thyrogen®, Genzyme Therapeutics, Cambridge, USA) was approved in Europe in 2005 as an alternative stimulation procedure to withdrawal during ablation. It allows patients to remain euthyroid on thyroid hormone therapy (that needs not to be withdrawn). However, this a costly drug (800 € per patient), whose economic efficiency needs to be checked.


Condition or disease Intervention/treatment Phase
Thyroid Cancer Drug: Thyrogen, thyroid hormone withdrawal, iode 131 Phase 3

Detailed Description:
This is a multicentric, randomized, controlled, open-label phase III clinical trial involving 26 French centers. It aims at comparing four strategies of management of postoperative radioiodine ablation, each strategy combining a method of TSH stimulation (thyroid hormone withdrawal or rhTSH (Thyrogen®, Genzyme)) and an activity of 131I (low-dose (1GBq, 30 mCi) or high-dose (3,7GBq, 100 mCi)).

Study Type : Interventional  (Clinical Trial)
Enrollment : 950 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Medico-Economic Comparison of Four Strategies of Radioiodine Ablation in Thyroid Carcinoma Patients - Estimabl
Study Start Date : February 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid




Primary Outcome Measures :
  1. the rate of successful postoperative thyroid ablation

Secondary Outcome Measures :
  1. the rate of long-term complications
  2. specific toxicities
  3. management costs (hospitalization, diagnosis tests and sick leave)
  4. quality of life and utility


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 year or older
  • Newly diagnosed differentiated papillary or follicular thyroid carcinoma who underwent total thyroidectomy between 30 and 60 days before randomization and treated by LT4 for at least one month.
  • Patients are all staged pT1<1cm N1 or pT1>1cm N0 N1 Nx or pT2 N0
  • The performance status is 0 or 1.
  • All patients will provide written consent to participate.

Exclusion Criteria :

  • partial thyroidectomy
  • patients treated by LT4 less than one month
  • time from thyroidectomy superior to 60 days at randomization
  • patients with Hurtle cancer or aggressive histology
  • Patients staged pT1<1cm N0 or T2 N1 or T3 or T4 or M1
  • patients for which the use of rhTSH is required for medical reasons
  • patients with major concurrent medical disorder (cardiac, renal, liver, respiratory)
  • patients with other malignancies (exception for in situ cervix uterine cancer, baso cellular skin cancer or breast cancer in remission for at least 2 years)
  • patients with recent history of drugs affecting thyroid function, including iodine containing medications or radiocontrast agents
  • patients with recent history of 131I whole body scan
  • pregant women or breast-feeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00435851


Contacts
Contact: Martin SHCLUMBERGER, PhD 00 33 014-211-6095 schlumbg@igr.fr

Locations
France
Institut Gustave Roussy Not yet recruiting
Villejuif, France, 94800
Contact: Martin SCHLUMBERGER, PhD    00 33 014-211-6095    schlumbg@igr.fr   
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
National Cancer Institute, France
Investigators
Principal Investigator: Martin SCHLUMBERGER, PhD Gustave Roussy, Cancer Campus, Grand Paris

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00435851     History of Changes
Other Study ID Numbers: Estimabl
CSET 1216
First Posted: February 16, 2007    Key Record Dates
Last Update Posted: February 19, 2007
Last Verified: February 2007

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