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
52 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 a very serious and often deadly cancer that causes rapid growth of a mass in the neck, leading to problems like breathing difficulty, swallowing issues, and pain. Surgery to remove the tumor completely is rarely successful, and many patients worsen so quickly that radiation or chemotherapy cannot be used afterward. This research focuses on patients with BRAF-mutated ATC and aims to increase the number of patients who achieve complete tumor removal by using targeted therapy before surgery. Participants will receive neo-adjuvant treatment with the drugs dabrafenib and trametinib, which inhibit BRAF/MEK. After 6 weeks of this treatment, doctors will evaluate whether the tumor can be surgically removed. If the tumor is resectable, surgery will be performed. If not, the targeted treatment will continue for another 6 weeks before a new assessment. After surgery, patients will continue dabrafenib and trametinib therapy for a total of 52 weeks. Those who cannot have surgery will remain on the targeted therapy. During the study, participants will be closely monitored through scans and laboratory tests to assess the success of tumor removal, treatment side effects, surgical complications, and survival outcomes. The main measure is the rate of complete tumor removal after 6 to 12 weeks of neo-adjuvant therapy. Additional evaluations include toxicity of the treatment, response to pre-surgery therapy, and survival without local or distant cancer spread. The study will follow participants for up to two years to gather these outcomes.
CONDITIONS
Brief 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...
- Provide informed consent.
- Be over 18 years old.
- Have WHO Performance Status 0 or I.
- Have histologically confirmed anaplastic thyroid cancer.
- Have confirmed BRAFV600E or BRAFV600K mutation in tumor tissue.
- Have no distant metastases (M0).
- Have a free or secured airway.
- Be able to swallow pills.
- Have completed disease staging including PET-CT and CT scans of neck, thorax, and abdomen.
- Have no prior anticancer systemic treatment.
- Have no prior radiotherapy to the site of interest.
- Meet specific laboratory value requirements for blood counts and organ function.
- Have no severe uncontrolled concurrent disease.
You will not qualify if you...
- Do not provide informed consent.
- Have had cancer within 2 years before ATC diagnosis (except basal cell skin cancer or in situ carcinoma).
- Have poorly differentiated transformation of previous differentiated thyroid cancer.
- Have distant metastases.
- Have medical conditions making study treatment hazardous or affecting toxicity assessment.
- Have history of congestive heart failure, active serious heart conditions, or severe valvular disease.
- Are pregnant or nursing.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 to 12 weeks
Participants receive neo-adjuvant treatment with dabrafenib/trametinib to reduce tumor size and assess surgical options.
1 to 2 visits for evaluation of resectability
Duration - 1 day
Participants undergo tumor resection if the tumor is deemed resectable after neo-adjuvant treatment.
1 surgical visit
Duration - Up to 52 weeks total treatment duration including neo-adjuvant period
Participants who had surgery receive adjuvant dabrafenib/trametinib treatment to reduce local and distant recurrences.
Regular visits during treatment period
Duration - Ongoing treatment duration not specified
Participants who are not eligible for surgery continue dabrafenib/trametinib treatment as ongoing therapy.
Visits as per treatment schedule
Trial Site Locations
Total: 1 location
1
Ellen Kapiteijn
Leiden, South Holland, Netherlands, 2300RC
Actively Recruiting
Research Team
E
Ellen Kapiteijn, MD, PhD
S
Saskia Luelmo, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here