NEO- and Adjuvant Targeted Therapy in Braf-mutated Anaplastic Cancer of the Thyroid (NEO-ATACT Study) (NEO-ATACT)
Anaplastic Thyroid Cancer
About this trial
This is an interventional treatment trial for Anaplastic Thyroid Cancer
Eligibility Criteria
Inclusion Criteria: Informed consent. Age over 18 years old. World Health Organization (WHO) Performance Status 0 or I. Histologically confirmed ATC (centrally reviewed). Confirmed presence of BRAFV600E/K mutation in primary tumor tissue. No distant metastases (M0). Free or secured airway. Able to swallow pills. Patients must have undergone complete disease staging including: PET-CT scan and CT-neck/thorax/abdomen. No prior anticancer systemic treatment (including chemotherapy, immunotherapy, oncolytic viral therapy, other systemic therapies). No prior radiotherapy to site of interest. Screening laboratory values must meet the following criteria: WBC ≥ 2.0x109/L, Neutrophils ≥ 1.0x109/L, Platelets ≥ 100 x109/L, Hemoglobin ≥ 6.5 mmol/L, AST ≤ 2.5 x ULN, ALT ≤ 2.5 x ULN, Total bilirubin ≤ 1.5 X ULN, INR and PTT in normal range, LDH < 2xULN. Serum creatinine ≤ 1.5 × ULN; or calculated creatinine clearance ≥ 50 mL/min by Cockcroft-Gault formula; or estimated glomerular filtration rate > 50 mL/min/1.73m2. Absence of additional severe and/or uncontrolled concurrent disease. Exclusion Criteria: 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. Underlying medical conditions that, in the Investigator's opinion, will make the administration of study treatment hazardous or obscure the interpretation of toxicity determination or adverse events History of congestive heart failure, active cardiac conditions, including unstable coronary syndromes, significant arrhythmias and severe valvular disease must be evaluated for risks of undergoing general anesthesia. Pregnancy or nursing.
Sites / Locations
- Ellen KapiteijnRecruiting
Arms of the Study
Arm 1
Experimental
neo-adjuvant and adjuvant braf/mek-inhibition
Participants will undergo neo-adjuvant treatment with dabrafenib/trametinib. After 6 weeks of BRAF/MEK inhibitors, participants will undergo an evaluation of resectability. If the tumor is resectable, patients undergo tumor resection. If not resectable, neo-adjuvant treatment continues for another 6 weeks followed by a new evaluation. All resected patients receive adjuvant dabrafenib/trametinib up to a total treatment duration of 52 weeks. If resection is not possible, patients will continue on dabrafenib/trametinib.