ESTIMABL1
Medico-Economic Comparison of Four Strategies of Radioiodine Ablation in Thyroid Carcinoma Patients - Estimabl
Phase 3N = 752NCT00435851
- Population
- Adults after total thyroidectomy for differentiated thyroid carcinoma: pT1 (diameter 1 cm or less) with N1 or Nx, pT1 (diameter more than 1 to 2 cm) with any N, or pT2N0; no distant metastasis; no iodine contamination (92% papillary cancer)
- Design
- Randomised phase 3 trial, 2-by-2 design, comparing two thyrotropin-stimulation methods (thyroid hormone withdrawal or recombinant human thyrotropin) and two radioiodine activities (1.1 GBq or 3.7 GBq). Ablation was assessed 8 months after radioiodine by neck ultrasonography and stimulated thyroglobulin; comparisons were based on an equivalence framework.
- Arms
- Low dose with thyrotropin alfa (experimental): 1.1 GBq radioiodine with recombinant human thyrotropin
- Low dose with hormone withdrawal (experimental): 1.1 GBq radioiodine with thyroid hormone withdrawal
- High dose with thyrotropin alfa (experimental): 3.7 GBq radioiodine with recombinant human thyrotropin
- High dose with hormone withdrawal (control): 3.7 GBq radioiodine with thyroid hormone withdrawal
- People
- Schlumberger M