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.
Informed consent.
Age over 18 years old.
World Health Organization (WHO) Performance Status 0 or I.
Histologically confirmed ATC (centrally reviewed).
No informed consent.
History of cancer within 2 years from diagnosis of ATC (exception: basal cell skin cancer, in situ carcinoma).
Poorly differentiated transformation of previous differentiated thyroid cancer.
Presence of distant metastases.
Single group
dabrafenib/trametinib
Drugbraf/mek-inhibition
primary endpoint of the study will be R0 resection rate (efficacy).
primary endpoint of the study will be R0 resection rate (efficacy).
Neo-adjuvant and adjuvant treatment related toxicity of dabrafenib/trametinib (according to CTCAE v. 5.0)
Neo-adjuvant and adjuvant treatment related toxicity of dabrafenib/trametinib (according to CTCAE v. 5.0) during 1 year of treatment with braf/mek-inhibition
30-day postoperative surgical complications
30-day postoperative surgical complications (within 30 days after surgery)
Histopathological response after neo-adjuvant treatment
Histopathological response after neo-adjuvant treatment: complete response (\<10% tumor cells), partial response (between more than 10% and up to 50% tumor cells), or no response (still more than 50% tumor cells)
Locoregional-free survival
Locoregional-free survival
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Leiden University Medical Center
Lead sponsor
Novartis
Collaborator
