OncoMatch/Clinical Trials/NCT06079333
NEO- and Adjuvant Targeted Therapy in Braf-mutated Anaplastic Cancer of the Thyroid (NEO-ATACT Study)
Is NCT06079333 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies dabrafenib/trametinib for anaplastic thyroid cancer.
Treatment: dabrafenib/trametinib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Thyroid Cancer
Biomarker criteria
Required: BRAF v600e/k
Performance status
WHO 0–1
Prior therapy
Cannot have received: anticancer systemic treatment
No prior anticancer systemic treatment (including chemotherapy, immunotherapy, oncolytic viral therapy, other systemic therapies)
Cannot have received: radiation therapy
No prior radiotherapy to site of interest
Lab requirements
Blood counts
WBC ≥ 2.0x10^9/L, Neutrophils ≥ 1.0x10^9/L, Platelets ≥ 100 x10^9/L, Hemoglobin ≥ 6.5 mmol/L
Kidney function
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
Liver function
AST ≤ 2.5 x ULN, ALT ≤ 2.5 x ULN, Total bilirubin ≤ 1.5 X ULN, INR and PTT in normal range, LDH < 2xULN
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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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