BRAF V600-mutant anaplastic thyroid cancer
Conditions
Interventions
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 resectabl
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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 = 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.
Exclusion criteria
Exclusion criteria: 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 cancer. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint of the study will be R0 resection rate (efficacy). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include grade III-IV toxicity according to CTCAE version 5.0 and 30-day postoperative complication rate (feasibility). | — |
Countries
Netherlands
Outcome results
None listed