2024-516126-54-00RecruitingPhase 2
NEOAC
(NEOAC) NEO- and Adjuvant Targeted therapy in braf-mutated Anaplastic Cancer of the Thyroid - a prospective, non-randomized, single center, open-label phase II study.
Source: EU CTIS (euclinicaltrials.eu) · Last updated 17 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study aims to increase the number of patients that undergo a successful R0 tumor resection after neo-adjuvant BRAF/MEK inhibitor treatment.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 24 Sept 2024
- Start date
- 21 Jan 2025
- Lead sponsor
- Leids Universitair Medisch Centrum (LUMC)
- Diseases
- Thyroid cancer
- EU CT number
- 2024-516126-54-00
- EudraCT number
- 2022-001908-17
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 20
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with anaplastic thyroid cancer that carries a BRAF V600E/K mutation, has not spread to distant organs, and has had no earlier cancer treatment.
- Age
- Over 18 years old
- Sex
- All sexes
- Disease stage
- Anaplastic thyroid cancer confirmed by tissue tests (centrally reviewed). No distant metastases (M0). Airway free or secured.
- Earlier treatment
- No earlier systemic cancer treatment (including chemotherapy, immunotherapy, oncolytic viral therapy). No earlier radiotherapy to the site of interest.
- Biomarker or test result
- BRAFV600E/K mutation confirmed in the primary tumor tissue.
Main reasons for not taking part
- Another cancer within 2 years before the ATC diagnosis (except basal cell skin cancer and in situ carcinoma)
- Poorly differentiated transformation of an earlier differentiated thyroid cancer
- Distant metastases
- Pregnancy or nursing
- Medical conditions that the investigator thinks would make treatment hazardous
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Poorly differentiated transformation of previous differentiated thyroid cancer
Other illness
- History of cancer within 2 years from diagnosis of ATC (exception: basal cell skin cancer, in situ carcinoma).
- 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
Other
- No informed consent.
- Presence of distant metastases.
- Pregnancy or nursing
Who the study is looking for
- Informed consent
- 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
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| LUMC | Leiden | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.