Systematic Radioiodine Administration (3.7 GBq I131 After rhTSH) Versus Decision of Radioiodine Treatment Guided by a Post-operative Work-up (INTERMEDIATE)
Systematic Radioiodine Administration (3.7 GBq I131 After rhTSH) Versus Decision of Radioiodine Treatment Guided by a Post-operative Work-up (INTERMEDIATE)
This trial is comparing two strategies in intermediate-risk differentiated thyroid cancer patients: Systematic radioiodine administration (3.7 GBq I131 after rhTSH) versus decision of radioiodine treatment guided by a post-operative work-up based on serum Tg values and diagnostic RAI scintigraphy.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 476 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicentric Phase III Trial Comparing Two Strategies in Intermediate-risk Differentiated Thyroid Cancer Patients: Systematic Radioiodine Administration (3.7 GBq I131 After rhTSH) Versus Decision of Radioiodine Treatment Guided by a Post-operative Work-up Based on Serum Tg Values and Diagnostic RAI Scintigraphy
Actual Study Start Date: March 2, 2020
Estimated Primary Completion Date: February 2026
Estimated Study Completion Date: February 2028
Arm:
- Active Comparator: RAI group
- Experimental: GUIDED FOLLOW-UP group
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 476 |
| Actual Study start date | 02 March 2020 |
| Estimated Study Completion Date | 01 February 2028 |