AuthorisedTherapeutic exploratory (Phase II)Interventional

(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.

This study, called NEOAC, is for people with a specific type of aggressive thyroid cancer that has a change in a gene called BRAF. Researchers want to see if giving two drugs, dabrafenib and trametinib, before and after surgery can help make the surgery more successful. The main goal is to find out if more patients can have all of their tumour removed during surgery after taking these drugs. The study will also check for any side effects of the drugs, how well the cancer responds to the treatment, and how people's health improves over time, including if the cancer comes back or spreads. This is a Phase II study, meaning it's exploring if the treatment works and is safe for this specific condition.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Leids Universitair Medisch Centrum (LUMC)

Enrolment target

Start

07 Oct 2024

ANAPLASTIC THYROID CANCER

What is this study about?

This research study, known as NEOAC, is designed for individuals who have a particularly aggressive type of thyroid cancer called anaplastic thyroid cancer. Specifically, it's for people whose cancer cells have a particular genetic change, often called a 'BRAF mutation'. This mutation can make the cancer grow and spread more quickly. The study is trying out a new approach using two specific drugs, dabrafenib and trametinib, which are targeted therapies. This means they are designed to specifically attack cancer cells with the BRAF mutation, rather than affecting all cells in the body like traditional chemotherapy.

The main idea behind this study is to give these drugs *before* surgery (this is called 'neo-adjuvant treatment') and then continue them *after* surgery ('adjuvant treatment'). The hope is that giving the drugs before surgery will shrink the tumour, making it easier for surgeons to remove all of the cancer during the operation. Removing all of the cancer (known as an 'R0 resection') is really important for improving a patient's long-term health.

Researchers will be carefully watching several things throughout the study. They'll be checking for any side effects from the drugs, how the thyroid cancer responds to the treatment before surgery, and how well patients recover after their operation. They will also look at how long people live without the cancer coming back in the same area (locoregional-free survival), without it spreading to other parts of the body (distant metastasis-free survival), and overall life expectancy. This will help understand if this new treatment plan is a safe and effective way to manage anaplastic thyroid cancer.

Key takeaways

This study explores targeted drugs (dabrafenib, trametinib) for aggressive thyroid cancer.
It aims to make surgery more successful by shrinking tumours beforehand.
Specifically for anaplastic thyroid cancer with a 'BRAF mutation'.
Drugs are given both before and after surgery.
Researchers will check for benefits, side effects, and long-term health.
Participation involves regular hospital visits, tests, and follow-up.

Who may be eligible?

This study is open to both men and women. To be considered, you must be at least 18 years old – there's no upper age limit, meaning older adults can also participate if they meet other criteria.

Key to eligibility is having been diagnosed with anaplastic thyroid cancer that has a specific genetic change, known as a BRAF mutation. This study is specifically designed for people with this type of cancer because the medications used target this particular genetic change.

Beyond these main points, the medical team will need to check other aspects of your health to make sure the study treatment is safe for you. This might include reviewing your general health, other medical conditions you have, and any other medications you are taking.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you at least 18 years old?
Have you been diagnosed with anaplastic thyroid cancer?
Has your cancer been tested and found to have a 'BRAF mutation'?
Are you able to attend regular hospital appointments for tests and treatment?
Are you willing to undergo surgery as part of the treatment plan?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first undergo several tests to officially confirm your diagnosis and overall health. If you are eligible, you will receive the study medications, dabrafenib and trametinib, for a period *before* your planned surgery. The exact duration will be decided by the study doctors. After your surgery, you will continue to receive these same medications for a period of time, as determined by the study plan.

Throughout your participation, you will have regular visits to the hospital or clinic. These visits will involve various assessments, such as blood tests, physical examinations, and scans (like CT or MRI scans), to monitor how you are responding to the treatment, check for any possible side effects, and track your overall health. Your medical team will explain the full schedule of appointments and tests. This study will involve ongoing follow-up for several years after your initial treatment to track your long-term health and ensure the cancer does not return or spread. The exact total duration of your participation, including follow-up, will be clearly explained by the research team.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving new treatments that could shrink your tumour and potentially make your surgery more successful than standard care. You will also be closely monitored by a dedicated medical team. However, there are potential risks, as the study drugs, dabrafenib and trametinib, can cause side effects. These can range from mild discomfort to more serious issues, which your medical team will discuss with you. You will be fully informed about all known risks before consenting, and you have the right to withdraw from the study at any time without affecting your future medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What is an anaplastic thyroid cancer?

It's a very rare and aggressive type of cancer that starts in the thyroid gland, which is in your neck. It can grow and spread quickly.

What does 'BRAF mutation' mean?

It means there's a specific change in one of your genes (the body's instructions) within the cancer cells. This change can make the cancer grow and spread, and certain drugs can specifically target it.

What are dabrafenib and trametinib?

These are two types of targeted drugs that are designed to attack cancer cells that have the 'BRAF mutation' specifically, aiming to stop their growth.

What does 'neo-adjuvant' and 'adjuvant' mean?

'Neo-adjuvant' means the treatment is given before surgery, and 'adjuvant' means it's given after surgery. The goal is to improve the chances of successful surgery and prevent the cancer from coming back.

Is this study suitable for everyone with thyroid cancer?

No, it's specifically for people with anaplastic thyroid cancer that has a particular genetic feature called a 'BRAF mutation'. Not all thyroid cancers have this.