Papillary thyroid cancer Trials in Disease

Study Comparing Two Treatment Strategies for Intermediate-Risk Thyroid Cancer Using Sodium Iodide (131I) in Patients with Post-Surgery Evaluation

This clinical trial is examining different ways to use radioiodine treatment in patients with intermediate-risk differentiated thyroid cancer. The study compares two treatment strategies: giving radioiodine routinely to all patients versus making treatment decisions based on specific tests performed after surgery.

Main inclusion criteria:

• Patients must have differentiated thyroid cancer classified as intermediate-risk, including papillary thyroid cancer without aggressive features, follicular thyroid cancer with limited blood vessel invasion, or Hürthle cell carcinoma
• Patients must have undergone complete removal of the thyroid gland (total thyroidectomy) 6 to 14 weeks before joining the study
• A normal neck ultrasound after surgery is required, or if unclear, specific additional tests must show no signs of remaining cancer
• Patients must be at least 18 years old and able to perform daily activities with few or no symptoms (Performance Status 0 or 1)
• Patients must have started thyroid hormone replacement therapy at least 6 weeks before enrollment
• Participants must agree to annual monitoring for 5 years and be part of the French social security system

Main exclusion criteria:

• Patients without intermediate-risk differentiated thyroid cancer
• Patients outside the specified age range
• Individuals considered part of a vulnerable population requiring special protection

Focus and goal:

The trial aims to determine whether a personalized approach to radioiodine treatment, guided by blood tests measuring thyroglobulin (a protein marker) and specialized imaging scans, can achieve similar or better outcomes compared to giving radioiodine routinely to all patients. Participants are randomly assigned to one of two groups: one receives radioiodine treatment according to a standard schedule, while the other group only receives treatment if post-surgery tests indicate it is necessary.

The study follows patients for several years to assess treatment response at 1, 3, and 5 years after enrollment. Researchers also evaluate quality of life, anxiety levels, fear of cancer returning, and side effects related to tear ducts, nasal passages, and salivary glands. The goal is to determine if the guided approach could lead to more personalized treatment plans while maintaining effective cancer control.

Investigational treatment:

The trial uses radioiodine treatment (RAI), which involves administering radioactive iodine in capsule form. This treatment, known as sodium iodide (131I), targets and destroys thyroid cancer cells. The radioactive iodine is absorbed by thyroid cells, where it releases radiation that eliminates remaining cancer cells after surgery. The dosage ranges from 37 to 5550 MBq depending on individual patient needs.