eo- and adjuvant targeted therapy in BRAF-mutated anaplastic cancer of the thyroid - NEO-ATACT

Academisch Medisch Centrum0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年4月9日

适应症

试验速览

暂无简介。

•1. Informed consent.
•2. Age over 18 years old.
•3. World Health Organization (WHO) Performance Status 0 or I.
•4. Histologically confirmed ATC (centrally reviewed).
•5. Confirmed presence of BRAFV600E/K mutation in primary tumor tissue.
•6. No distant metastases (M0).
•7. Free or secured airway.
•8. Able to swallow pills.
•9. Patients must have undergone complete disease staging including: PET-CT scan
•and CT-neck/thorax/abdomen.
•10. No prior anticancer systemic treatment (including chemotherapy,
•immunotherapy, oncolytic viral therapy, other systemic therapies).
•11. No prior radiotherapy to site of interest.
•12. 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.
•13. Absence of additional severe and/or uncontrolled concurrent disease.

•1. No informed consent.
•2. History of cancer within 2 years from diagnosis of ATC (exception: basal
•cell skin cancer, in situ carcinoma).
•3. Poorly differentiated transformation of previous differentiated thyroid
•4. Presence of distant metastases.
•5. 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.
•6. 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.
•7. Pregnancy or nursing.

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