Phase III Study Comparing Preventive Central Neck Dissection Versus No Dissection in Adults with Low-risk Papillary Thyroid Cancer

What this Trial Is About

Researchers are evaluating the benefits and risks of prophylactic central lymph node dissection in patients with low-risk papillary thyroid carcinoma PTC, specifically in those with primary tumors classified as cT1b-T2N0. PTC is the most common thyroid cancer, usually treated with surgery, but the need for removing lymph nodes that do not show obvious cancer involvement remains unclear. This study aims to clarify whether routine removal of these lymph nodes improves treatment response, reduces recurrence, and helps guide decisions about radioactive iodine therapy, while considering the risk of complications. The study randomly assigns participants to one of two groups one group undergoes prophylactic central neck dissection on the side of the lesion, and the other group does not receive central neck dissection. Surgery is the primary intervention, and the trial is open-label and multicenter. The study includes adult patients aged 18 to 70 years with specific tumor sizes and no suspicious lymph nodes detected before surgery. Participants will be followed for at least one year to assess treatment response, measured by excellent response rates, and recurrence-free survival at one and two years. Assessments include monitoring thyroglobulin and its antibodies to evaluate short-term treatment outcomes. Study visits and follow-up tests will help track disease status and safety. The total participation duration is expected to cover these time points, supporting evaluation of long-term benefits and risks of the surgical approach.

A Prospective, Open-label, Multicenter, Randomized Controlled Phase III Study of Prophylactic Central Neck Dissection in Low-risk Papillary Thyroid Cancer