RecruitingPhase 2NCT06079333

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

Sponsor

Leiden University Medical Center

Enrollment

20 participants

Start Date

Jan 1, 2023

Study Type

INTERVENTIONAL

Conditions

Anaplastic Thyroid Cancer

Summary

Anaplastic thyroid cancer (ATC) is an almost invariable lethal cancer in humans. Most patients present with a rapid progressive mass in the neck with progressive complaints like dyspnoea, dysphagia or pain. The risk of suffocation is the main reason for rapid surgical intervention, but we know from literature that an oncological resection with clear margins is seldomly achieved. Some patients deteriorate that fast after surgery that radiation therapy and/or chemotherapy is not feasible anymore. Patients with BRAF-mutated ATC already have shown to benefit from targeted BRAF/MEK inhibition. This study aims to increase the number of patients that undergo a successful R0 tumor resection after neo-adjuvant BRAF/MEK inhibitor treatment.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (NEO-ATACT) is testing a targeted drug combination — dabrafenib and trametinib, which block the BRAF mutation — given before and after surgery for anaplastic thyroid cancer (ATC), one of the most aggressive cancers. Only patients whose tumors have the BRAFV600E or BRAFV600K mutation are eligible. **You may be eligible if...** - You are over 18 years old - You have been diagnosed with anaplastic thyroid cancer confirmed by tissue testing (reviewed centrally) - Your tumor has a BRAFV600E or BRAFV600K mutation confirmed by testing - Your cancer has not spread to distant sites (M0) - Your airway is clear or secured - You are able to swallow pills - You have had full staging workup **You may NOT be eligible if...** - Your thyroid cancer does not have a BRAF mutation - Your cancer has spread to distant organs - You cannot swallow medications - You have a poor overall health status (WHO Performance Status 2 or higher) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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