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

Phase 2

Recruiting

• Conditions: BRAF V600-mutant anaplastic thyroid cancer; 10014713

• Registration Number: NL-OMON51864
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 20

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint of the study will be R0 resection rate (efficacy). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints include grade III-IV toxicity according to CTCAE version<br /><br>5.0 and 30-day postoperative complication rate (feasibility).</p><br>