Actively Recruiting
NEO- and Adjuvant Targeted Therapy in Braf-mutated Anaplastic Cancer of the Thyroid (NEO-ATACT Study)
Led by Leiden University Medical Center · Updated on 2023-10-12
20
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
L
Leiden University Medical Center
Lead Sponsor
N
Novartis
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 or pain. The risk of suffocation is the main reason for rapid surgical intervention, but we know from literature that an oncological resection with clear margins is seldomly achieved. Some patients deteriorate that fast after surgery that radiation therapy and/or chemotherapy is not feasible anymore. Patients with BRAF-mutated ATC already have shown to benefit from targeted BRAF/MEK inhibition. This study aims to increase the number of patients that undergo a successful R0 tumor resection after neo-adjuvant BRAF/MEK inhibitor treatment.
CONDITIONS
Official Title
NEO- and Adjuvant Targeted Therapy in Braf-mutated Anaplastic Cancer of the Thyroid (NEO-ATACT Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Informed consent provided.
- Age over 18 years old.
- World Health Organization (WHO) Performance Status 0 or I.
- Histologically confirmed anaplastic thyroid cancer (centrally reviewed).
- Confirmed presence of BRAFV600E/K mutation in primary tumor tissue.
- No distant metastases (M0).
- Free or secured airway.
- Able to swallow pills.
- Completed full disease staging including PET-CT scan and CT of neck, thorax, and abdomen.
- No prior anticancer systemic treatment (chemotherapy, immunotherapy, oncolytic viral therapy, or other systemic therapies).
- No prior radiotherapy to the site of interest.
- Screening laboratory values meeting specific blood count and liver/kidney function criteria.
- No additional severe or uncontrolled concurrent disease.
You will not qualify if you...
- No informed consent.
- History of cancer within 2 years before diagnosis of ATC (except basal cell skin cancer or in situ carcinoma).
- Poorly differentiated transformation of previous differentiated thyroid cancer.
- Presence of distant metastases.
- Medical conditions that make study treatment unsafe or interfere with toxicity assessment.
- History of congestive heart failure or active serious heart conditions needing evaluation before anesthesia risks.
- Pregnancy or nursing.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Ellen Kapiteijn
Leiden, South Holland, Netherlands, 2300RC
Actively Recruiting
Research Team
E
Ellen Kapiteijn, MD, PhD
CONTACT
S
Saskia Luelmo, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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