Active not recruitingPHASE3INTERVENTIONAL

Trial of Laryngeal Preservation Comparing Induced CT Followed by RT vs CT Concomitant to RT

This study is for people with a specific type of throat cancer (larynx or hypopharynx cancer). Doctors are comparing two different approaches to treatment that combine chemotherapy (cancer-fighting drugs) and radiotherapy (high-energy rays). The main goal is to find out which treatment plan is better at preserving the voice box (larynx) and keeping it working well, so patients can avoid needing surgery to remove it. Previously, major surgery was common. Now, scientists are trying to improve treatments so people can keep their voice box. This study hopes one of these new approaches will lead to more people living two years after treatment with a working voice box.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Groupe Oncologie Radiotherapie Tete et Cou

Enrolment target

256

Start

25 Jun 2015

Estimated completion

01 Nov 2028

Head and Neck Squamous Cell Carcinoma

What is this study about?

This study is for individuals diagnosed with a specific type of cancer found in the throat, specifically in the voice box (larynx) or the area just above it (hypopharynx). Doctors are comparing two different ways to treat this cancer using a combination of chemotherapy (powerful medicines that kill cancer cells) and radiotherapy (using high-energy rays to destroy cancer cells).

The main aim of this research is to see if one of these combined treatments is better at helping people survive for at least two years after treatment, while also making sure their voice box continues to work properly. For a long time, the usual treatment for these types of cancer, especially when they were more advanced, involved a big operation to remove the voice box entirely. This surgery, called a total laryngectomy, was very effective at getting rid of the cancer, but it meant a big change to a person's life and voice.

Now, medical science has made progress, and doctors are looking for ways to treat this cancer more effectively without needing to remove the voice box. Previous studies have shown that giving chemotherapy before radiotherapy, or giving chemotherapy at the same time as radiotherapy, can be good options for saving the voice box. This study wants to directly compare these two approaches in a careful way to find the best possible treatment that offers both good cancer control and the best chance of keeping your voice box working.

Key takeaways

This study compares two ways of giving chemotherapy and radiotherapy for certain throat cancers.
The main goal is to find the best treatment to save your voice box and keep it working well.
It aims to avoid the need for major surgery to remove the voice box.
Participants will receive either chemotherapy followed by radiotherapy, or chemotherapy given at the same time as radiotherapy.
The study hopes to improve the chances of keeping your voice box working for at least two years after treatment.
You will be closely monitored with regular tests during and after treatment.

Who may be eligible?

This study is looking for adults aged between 18 and 75 who have been diagnosed with a specific type of throat cancer in their voice box or the area above it. It's important that your cancer hasn't spread to other parts of your body and that you haven't received any treatment for this cancer before. You also need to be generally well and able to manage daily activities.

There are also some medical checks involved. For example, your blood tests (like blood count, liver, and kidney function) need to be within a healthy range. You shouldn't have any other unmanaged cancers or be taking high doses of steroids regularly. If you are a woman or man who could have children, you'll need to agree to use effective birth control during the study and for at least six months after.

Some people can't join the study, such as those with very advanced cancer that has spread widely, or if the cancer has grown into the cartilage of the voice box in a very specific way. You also can't have taken part in another recent clinical trial or be receiving other cancer treatments at the same time.

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 between 18 and 75 years old?
Do you have a specific type of throat cancer (larynx or hypopharynx)?
Has your cancer not spread to other parts of your body?
Have you not received any previous cancer treatment for this condition?
Are your blood test results (like blood count, liver, and kidney function) within healthy ranges?
Are you willing and able to use effective birth control if applicable?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first undergo a series of medical tests to confirm you are suitable. Once you're in the study, you'll be put into one of two groups by chance, like flipping a coin. Both groups will receive a combination of chemotherapy drugs (Docetaxel, Cisplatin, and Fluorouracil) and radiotherapy, but the timing of these treatments will be different depending on your group.

You will have regular hospital visits for your chemotherapy and radiotherapy treatments. During these visits, the medical team will closely monitor your health, check for any side effects, and perform tests such as blood work and scans to see how you are responding to the treatment. After your main treatment finishes, you'll continue to have follow-up appointments and checks for at least two years to make sure the cancer hasn't come back and to see how well your voice box is working. The exact number of visits and tests will be explained to you in detail by the study team, and you'll know exactly what to expect.

Potential risks and benefits

Taking part in this study might offer you access to new treatments that aim to save your voice box, which could be beneficial. However, like all medical treatments, there are potential side effects from chemotherapy and radiotherapy, which could include feeling unwell, tiredness, hair loss, or irritation to the treated area. The study team will explain these in detail. While we hope for better results, there's no guarantee the new treatment will be more effective than standard care, and there's a risk it might not work as well for everyone. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Centre Jean Bernard
Verified postcode
Le Mans, France

Common questions

What is the voice box (larynx) and why is it important?

The larynx, or voice box, is a part of your throat that contains your vocal cords. It's vital for speaking, breathing, and swallowing. This study aims to help keep it working.

What's the difference between chemotherapy and radiotherapy?

Chemotherapy uses powerful medicines given, often through a drip, to kill cancer cells throughout the body. Radiotherapy uses high-energy rays, like X-rays, aimed directly at the cancer to destroy cancer cells in that specific area.

Will I have to have surgery if I join this study?

The main goal of this study is to find a way to treat your cancer *without* needing to remove your voice box through surgery. The treatments being tested are designed to try and save it.

How long will I be in the study?

You'll have an initial treatment period with chemotherapy and radiotherapy. After that, you'll be followed up regularly for at least two years to check on your health and the success of the treatment.

What does 'survival without laryngeal dysfunction' mean?

It means how many people are still alive two years after treatment and whose voice box is still working properly, allowing them to speak, breathe, and swallow without major problems.