CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 368 target
Drug / intervention
Systematic RAI-treatment +1 moredrug
Likely dose
Not stated in record
Key inclusion· 12
  • ✓Differentiated thyroid cancer (PTC, FTC, or HCC) classified as intermediate-risk per TNM 2017
  • ✓T1b or T2 with minimal extra-thyroid extension and/or pN1 with nodal dimension 2-10mm, without extra-capsular invasion, ≤10 metastatic nodes
  • ✓T1aN1 with nodal dimension 2-10mm, without extra-capsular invasion, ≤10 metastatic nodes
  • ✓Total thyroidectomy with complete macroscopic tumor resection (R0 or R1)
Key exclusion· 17
  • ✕Medullary or anaplastic thyroid cancer
  • ✕Poorly differentiated carcinoma
  • ✕FTC with ≥4 foci of vascular invasion
  • ✕PTC with aggressive variants (tall cell, columnar cell, diffuse sclerosing, hobnail)

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NCT04290663Phase 3RecruitingHigh Momentum
Long Recruiting
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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

Centre Francois Baclesse·interventional·Posted Mar 2, 2020·Updated Jun 25, 2026

In Brief

A Phase 3 clinical trial evaluating Systematic RAI-treatment and Decision of RAI-treatment guided by a post-operative assessment for Thyroid Cancer and Intermediate Risk. Currently recruiting, targeting 368 participants across 29 sites.

Signals

Enrolling ahead of pace

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsThyroid Cancer, Intermediate Risk
CountriesFrance
CollaboratorsFrench cancer Institute INCa

Timeline

Phase 3Recruiting
20202021202220232024202520262027202820292030203120322033
First PostedMar 2, 2020
Enrollment StartMar 2, 2020
Primary CompletionFeb 1, 2031
Study CompletionFeb 1, 2033
TodayJul 2, 2026
Enrollment to primary: 10.9 yearsPosted 6.3 years agoPrimary completion in 4.6 years

Interventions

Systematic RAI-treatmentdrug

Administration of 3.7 GBq (100 mCi) or 1,1 GBq (30 mCi) of I131 at the choice of the investigator after rhTSH-stimulation

Decision of RAI-treatment guided by a post-operative assessmentother

The decision-making for the administration of an adapted RAI-treatment will be taken according to the following criteria: * No RAI treatment if Tg/LT4 ≤1 ng/mL and rhTSH-sTg ≤10 ng/mL and normal diagnostic RAI-scintigraphy * 1.1 GBq after rhTSH if Tg/LT4\>1 ng/mL or rhTSH-sTg\>10 ng/mL and normal diagnostic RAI-scintigraphy. * 3.7 GBq after rhTSH if metastatic lymph-node(s) detected on diagnostic RAI-scintigraphy without distant metastasis * 3.7 GBq after hormone withdrawal if distant metastasis detected on diagnostic RAI-scintigraphy or on the hybrid CT scan of the SPECT-CT acquisition