NEOAC
Key facts
- Where
- Leiden, HollandiaSee the site
- Phase
- 2. fázis
Where in Hollandia
- LUMCLeiden, HollandiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Leids Universitair Medisch Centrum (LUMC)
- Trial code
- EU 2024-516126-54-00
- Record updated
- 2025. február 17.
- Original description
This study aims to increase the number of patients that undergo a successful R0 tumor resection after neo-adjuvant BRAF/MEK inhibitor treatment.Read full original descriptionShow less
(NEOAC) NEO- and Adjuvant Targeted therapy in braf-mutated Anaplastic Cancer of the Thyroid - a prospective, non-randomized, single center, open-label phase II study.
This study aims to increase the number of patients that undergo a successful R0 tumor resection after neo-adjuvant BRAF/MEK inhibitor treatment.
Inclusion: Informed consent; 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; 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.
Exclusion: Poorly differentiated transformation of previous differentiated thyroid cancer; History of cancer within 2 years from diagnosis of ATC (exception: basal cell skin cancer, in situ carcinoma); 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; No informed consent; Presence of distant metastases; Pregnancy or nursing.