Targeted Neo-Adjuvant and Adjuvant Therapy Using Dabrafenib and Trametinib for Patients with BRAF-Mutated Anaplastic Thyroid Cancer

What this Trial Is About

Anaplastic thyroid cancer ATC is a very serious and often deadly cancer that causes rapid growth of a mass in the neck, leading to problems like breathing difficulty, swallowing issues, and pain. Surgery to remove the tumor completely is rarely successful, and many patients worsen so quickly that radiation or chemotherapy cannot be used afterward. This research focuses on patients with BRAF-mutated ATC and aims to increase the number of patients who achieve complete tumor removal by using targeted therapy before surgery. Participants will receive neo-adjuvant treatment with the drugs dabrafenib and trametinib, which inhibit BRAFMEK. After 6 weeks of this treatment, doctors will evaluate whether the tumor can be surgically removed. If the tumor is resectable, surgery will be performed. If not, the targeted treatment will continue for another 6 weeks before a new assessment. After surgery, patients will continue dabrafenib and trametinib therapy for a total of 52 weeks. Those who cannot have surgery will remain on the targeted therapy. During the study, participants will be closely monitored through scans and laboratory tests to assess the success of tumor removal, treatment side effects, surgical complications, and survival outcomes. The main measure is the rate of complete tumor removal after 6 to 12 weeks of neo-adjuvant therapy. Additional evaluations include toxicity of the treatment, response to pre-surgery therapy, and survival without local or distant cancer spread. The study will follow participants for up to two years to gather these outcomes.

NEO- and Adjuvant Targeted Therapy in Braf-mutated Anaplastic Cancer of the Thyroid (NEO-ATACT Study)