Multicentric Phase III Trial Comparing Two Strategies in Intermediate-risk Differentiated Thyroid Cancer Patients: Systematic Radioiodine Administration Versus Decision of Radioiodine Treatment Guided by a Post-operative Work-up Based on Serum Tg Values and Diagnostic RAI Scintigraphy
This trial is comparing two strategies in intermediate-risk differentiated thyroid cancer patients: Systematic radioiodine administration versus decision of radioiodine treatment guided by a post-operative work-up based on serum Tg values and diagnostic RAI scintigraphy
• Subgroup of patients with differentiated thyroid cancer and intermediate-risk defined as follows according to TNM 2017:
‣ Papillary thyroid cancer (PTC) without aggressive subtype, follicular thyroid cancer (FTC) (with \< 4 foci of vascular invasion) or Hürthle cell carcinoma (HCC)
⁃ T1b or T2 with minimal extra-thyroid extension into the perithyroidal soft tissues and/or pN1 with largest nodal dimension between 2 and 10 mm, without extra-capsular invasion and with a number of metastatic nodes ≤ 10
⁃ T1aN1 with largest nodal dimension between 2 and 10 mm, without extra-capsular invasion and with a number of metastatic nodes ≤ 10
• Patient treated by total thyroidectomy with macroscopically complete tumor resection (R0 or R1) ± neck dissection
• Total thyroidectomy performed within 6 to 14 10 weeks before randomization
• Patient with or without anti-thyroglobulin antibodies (TgAb)
• No known distant metastases
• Normal post-operative neck ultrasound (US) or if doubtful US, negative cytology and normal Tg value (\<10 ng/ml) in FNA washout fluid
• Post-operative LT4 treatment initiated at least 6 weeks before randomization
• Performance Status 0 or 1
• Patients aged 18 years or older
• Signed informed consent form
• Patient who agrees to be followed annually during 5 years
• Patient affiliated to the French social security system