Phase III Study Comparing Systematic Radioiodine Treatment to Treatment Based on Post-Operative Tests in Intermediate-Risk Thyroid Cancer Patients

What this Trial Is About

This trial is focused on patients with intermediate-risk differentiated thyroid cancer. It aims to compare two approaches for administering radioiodine treatment a systematic administration versus a decision guided by post-operative evaluations including serum thyroglobulin levels and diagnostic radioiodine scintigraphy. The study is a Phase III, multicenter trial sponsored by Centre Francois Baclesse, designed to evaluate treatment strategies for this specific thyroid cancer subgroup. Participants will be assigned to one of two groups. The first group receives a systematic radioiodine treatment with doses of either 3.7 GBq or 1.1 GBq of I131, determined by the investigator after recombinant human TSH stimulation. The second groups treatment decision is personalized based on post-operative assessments no treatment if certain thyroglobulin thresholds and scintigraphy are normal lower or higher doses if specific serum levels or metastases are detected, with hormone withdrawal used in some cases. Treatment is guided by these detailed clinical criteria. Throughout the trial, participants will be monitored for tumor response at 36 months after randomization, focusing on the rate of excellent tumoral response. Secondary measures include quality of life, salivary, nasal, and tear duct toxicities, management costs, and anxiety levels assessed at various times during and after treatment. Follow-up will continue annually for five years. Patients undergo evaluations such as serum tests and imaging to guide treatment decisions and monitor outcomes during the study period.

Systematic Radioiodine Administration Versus Decision of Radioiodine Treatment Guided by a Post-operative Work-up