Know Cancer

forgot password

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

Phase 3
18 Years
Not Enrolling
Thyroid Cancer

Thank you

Trial Information

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

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)).

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

Type of Study:


Study Design:

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

Outcome Measure:

the rate of successful postoperative thyroid ablation

Principal Investigator


Investigator Role:

Principal Investigator

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

February 2007

Completion Date:

Related Keywords:

  • Thyroid Cancer
  • Carcinoma
  • Thyroid Neoplasms
  • Thyroid Diseases