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

Thyroid Cancer Clinical Trial

— Estimabl  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00435851
• Other study ID #: Estimabl
• Secondary ID: CSET 1216
• Status: Not yet recruiting
• Phase: Phase 3
• First received: February 15, 2007
• Last updated: February 16, 2007
• Start date: February 2007

Study information

• Verified date: February 2007
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: Martin SHCLUMBERGER, PhD
• Phone: 00 33 014-211-6095
• Email: schlumbg[@]igr.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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 It allows patients to remain euthyroid on thyroid hormone therapy (that needs not to be withdrawn).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.

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)).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 950
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Drug:
• Thyrogen, thyroid hormone withdrawal, iode 131

Locations

Country	Name	City	State
France	Institut Gustave Roussy	Villejuif

Sponsors (2)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris	National Cancer Institute, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the rate of successful postoperative thyroid ablation
Secondary	the rate of long-term complications
Secondary	specific toxicities
Secondary	management costs (hospitalization, diagnosis tests and sick leave)
Secondary	quality of life and utility