Targeted therapy for BRAF-mutated anaplastic thyroid cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and efficacy of neo-adjuvant and adjuvant treatment using dabrafenib and trametinib in patients with BRAF-mutated anaplastic thyroid cancer (ATC). The approach aims to improve surgical outcomes by increasing the likelihood of achieving clear surgical margins after treatment. Patients will receive targeted therapy before surgery to address micro/macrometastases and potentially enhance their eligibility for complete tumor resection. The study is conducted at a single center and focuses on a specific genetic mutation associated with ATC.

Why it matters

Who can join: the full rules

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 ≤ 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.

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.

Where it's running

• Ellen Kapiteijn
  Leiden, South Holland, Netherlands Recruiting

Study contacts

• Principal investigator: Ellen Kapiteijn, MD, PhD — Leiden University Medical Center
• Study coordinator: Ellen Kapiteijn, MD, PhD
• Email: h.w.kapiteijn@lumc.nl
• Phone: 0031-71-5263486

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.