NEO- and Adjuvant Targeted Therapy in Braf-mutated Anaplastic Cancer of the Thyroid (NEO-ATACT Study)

Launched by LEIDEN UNIVERSITY MEDICAL CENTER · Oct 5, 2023

Keywords

ClinConnect Summary

The NEO-ATACT study is a clinical trial exploring new treatment options for patients with anaplastic thyroid cancer (ATC), a very aggressive form of thyroid cancer that often progresses quickly. The trial focuses on using targeted therapies that specifically target a gene mutation known as BRAF. The goal is to see if giving these targeted therapies before surgery can help more patients successfully have their tumors removed. This is important because many patients don’t have surgery due to how quickly the cancer spreads or other complications.

To be eligible for this study, participants need to be at least 18 years old, have been diagnosed with ATC that has a specific mutation, and not have any distant spread of the cancer. They should also be able to swallow pills and have a clear airway. Importantly, they should not have received any previous cancer treatments or radiation for this type of cancer. If someone joins the study, they can expect to receive the targeted therapy, and their progress will be closely monitored to see how well the treatment works before surgery. Overall, this trial may offer hope to patients with a challenging diagnosis by exploring effective treatment options.

Gender

ALL

Eligibility 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 ≤ 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.