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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorLeiden University Medical Center

About this trial

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 criteria

Qualifiers

Informed consent.

Age over 18 years old.

World Health Organization (WHO) Performance Status 0 or I.

Histologically confirmed ATC (centrally reviewed).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • dabrafenib/trametinib

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators