Status:
RECRUITING
NEO- and Adjuvant Targeted Therapy in Braf-mutated Anaplastic Cancer of the Thyroid (NEO-ATACT Study)
Lead Sponsor:
Leiden University Medical Center
Collaborating Sponsors:
Novartis
Conditions:
Anaplastic Thyroid Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Anaplastic thyroid cancer (ATC) is an almost invariable lethal cancer in humans. Most patients present with a rapid progressive mass in the neck with progressive complaints like dyspnoea, dysphagia o...
Detailed Description
Unmet need ATC is a very serious condition and is, apart from a few exclusive cases, always lethal. Many patients suffer uncontrollable loco-regional disease with even so uncontrollable complaints of ...
Eligibility Criteria
Inclusion
- Informed consent.
- Age over 18 years old.
- World Health Organization (WHO) Performance Status 0 or I.
- Histologically confirmed ATC (centrally reviewed).
- Confirmed presence of BRAFV600E/K mutation in primary tumor tissue.
- No distant metastases (M0).
- Free or secured airway.
- Able to swallow pills.
- Patients must have undergone complete disease staging including: PET-CT scan and CT-neck/thorax/abdomen.
- No prior anticancer systemic treatment (including chemotherapy, immunotherapy, oncolytic viral therapy, other systemic therapies).
- No prior radiotherapy to site of interest.
- 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.
- Absence of additional severe and/or uncontrolled concurrent disease.
Exclusion
- No informed consent.
- History of cancer within 2 years from diagnosis of ATC (exception: basal cell skin cancer, in situ carcinoma).
- Poorly differentiated transformation of previous differentiated thyroid cancer.
- Presence of distant metastases.
- 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
- 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.
- Pregnancy or nursing.
Key Trial Info
Start Date :
January 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06079333
Start Date
January 1 2023
End Date
January 1 2028
Last Update
October 12 2023
Active Locations (1)
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1
Ellen Kapiteijn
Leiden, South Holland, Netherlands, 2300RC