Active not recruitingPHASE2INTERVENTIONAL

Trial Evaluating the Tolerance and Safety of Durvalumab - RT Combination for Treatment in SCCHN

This study is for people with a type of head, neck, or throat cancer called Squamous Cell Carcinoma. Researchers are testing a new treatment that combines a drug called durvalumab with a specific kind of radiation therapy. Usually, radiation is given to a wide area of the neck to stop cancer from spreading, but this can cause side effects. This study aims to see if giving radiation only to the main tumour and a tiny nearby area, along with durvalumab, can control the cancer just as effectively but with fewer side effects. The hope is to find a treatment that works well and is gentler, especially for patients who might be more sensitive to standard treatments. All patients in the study will be followed for at least 3 years.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Groupe Oncologie Radiotherapie Tete et Cou

Enrolment target

Start

17 Jul 2019

Estimated completion

01 Aug 2026

HNSCC

What is this study about?

This study is for people diagnosed with a specific type of head, neck, or throat cancer called Squamous Cell Carcinoma. The main goal is to find a better and less harsh way to treat this cancer. Currently, a common treatment involves radiation therapy that covers a wide area of the neck, even if cancer hasn't been seen there, to prevent it from coming back. While this approach works, it can also cause unwanted side effects due to the large area treated.

Researchers are investigating a new approach. They want to see if combining a drug called durvalumab with a more focused type of radiation therapy can be just as effective in controlling the cancer, but with fewer side effects. The focused radiation would only target the main tumour and a very small, nearby area, rather than a large part of the neck. Durvalumab is a type of immunotherapy that helps the body's own immune system fight cancer.

The thinking behind this study is that durvalumab might boost the body's defences enough to replace the need for wide-area radiation, potentially reducing treatment-related problems. This could be particularly helpful for patients who might find standard treatments too difficult or who are more likely to experience complications. The study will carefully monitor if this new combination controls the cancer in the neck just as well as the standard, broader radiation treatment.

Key takeaways

It's for a type of head, neck, or throat cancer.
It combines a drug (durvalumab) with a new, focused radiation therapy.
The goal is fewer side effects while being just as effective.
It's particularly interested in patients who might struggle with standard strong treatments.
Participation involves regular checks and a long follow-up period (at least 3 years).

Who may be eligible?

To be considered for this study, you need to be at least 18 years old, with no upper age limit. You must have a type of head, neck, or throat cancer called Squamous Cell Carcinoma that hasn't been treated before, and doctors should not have found cancer spread to many lymph nodes in your neck. Your general health should be good enough to participate, rated as an ECOG score of 0, 1, or 2.

Crucially, this study is particularly looking for patients who might struggle with standard, more intense treatments. This could mean you have a few other health conditions, are aged 70 or over and assessed as frail, or have health issues that make a strong chemotherapy like cisplatin or carboplatin-5FU unsuitable for you. Your kidney function also needs to be within a certain range.

Finally, the cancer must be in your mouth, throat, or voice box area. Doctors will also need to be able to get a sample of your cancer tissue from before treatment. You need to be willing and able to attend all study appointments and follow the plan for the entire study duration.

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 18 years or older?
Do you have untreated Squamous Cell Carcinoma of the head, neck, or throat?
Is your general health good enough for studies (ECOG 0-2)?
Are you considered 'fragile' or 'unfit' for standard strong chemotherapy?
Are you willing to attend all study visits and follow the plan for at least 3 years?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive two main treatments: the drug durvalumab and a specific type of radiation therapy. The radiation therapy will be targeted only to your main tumour and a small area next to it, not the wider neck area usually treated. You will have regular appointments for check-ups, scans (like MRI or PET-CT), and blood tests to monitor your health and how the treatment is working. Doctors will also keep a close eye on your original cancer site and your neck for any signs of the cancer returning.

Throughout the study, you'll need to follow the treatment plan and attend all scheduled visits and examinations. This includes a follow-up period after your main treatment ends, which will last for at least 36 months (3 years). This long follow-up helps researchers see the long-term effects of the treatment.

Potential risks and benefits

Participating in this study might offer the benefit of a newer treatment approach that aims to be as effective as standard care but potentially with fewer side effects due to less extensive radiation. However, as with any medical study, there are potential risks, and the new combination might not work for everyone, or it could have side effects that are not yet fully understood. You will be closely monitored for any problems. Remember, taking part in a study is always voluntary, and you have the right to withdraw at any time without affecting your future medical care.

Locations (2)

Institut Sainte Catherine
Verified postcode
Avignon, France
Centre Eugene Marquis
Verified postcode
Rennes, France

Common questions

What is 'durvalumab'?

Durvalumab is a type of medicine known as immunotherapy. It works by helping your body's own immune system find and fight cancer cells.

What does 'radiation therapy restricted to the primary tumor' mean?

This means that the radiation treatment will only be given to the main cancerous area and a very small, nearby region, rather than a larger section of your neck. The goal is to reduce side effects.

Why is this study looking for patients who are 'fragile' or 'unfit' for standard treatments?

The study aims to find a gentler but still effective treatment option for patients who might struggle more with the standard, more intense types of chemotherapy and radiation, such as older patients or those with other health conditions.

How long will I be followed up in this study?

You will be followed up for at least 36 months (3 years) to see the long-term effects and how well the treatment works over time.

Will I still get regular scans and check-ups for cancer returning in my neck?

Yes, even with the more focused radiation, your medical team will closely monitor your neck with regular examinations and imaging scans to check for any signs of cancer.