Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A phase II trial of radiotherapy-durvalumab without prophylactic neck irradiation in squamous cell carcinoma of the head and neck (REWRITe)

This study is for people recently diagnosed with a type of head and neck cancer. It's testing if combining standard radiotherapy (a treatment that uses high-energy rays to kill cancer cells) with a drug called durvalumab (also known as IMFINZI) can be an effective way to treat the cancer without always needing surgery on the neck area. Researchers want to see how well this combination stops the cancer from growing in the neck over one year. They will also look at how patients feel, any side effects, and how long people stay well. This is a Phase II study, which means it's an early step to see if this new treatment approach is safe and effective.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Groupe Oncologie Radiotherapie Tete Cou

Enrolment target

Start

24 Jul 2024

Untreated squamous cell carcinoma of the head and neck

What is this study about?

This research study is about finding better ways to treat a specific type of cancer called squamous cell carcinoma, which affects the head and neck area. Currently, treatment often includes radiotherapy, which uses high-energy beams to target and destroy cancer cells. Sometimes, doctors also remove lymph glands in the neck with surgery, even if they don't see cancer there, as a preventative measure. This study wants to see if we can avoid this preventative neck surgery for some patients.

The study combines radiotherapy with a new drug called durvalumab (you might hear it called IMFINZI). Durvalumab is an immunotherapy drug that works by helping your body's own immune system fight the cancer. The main goal is to find out if this combination can effectively control the cancer in the neck area for at least a year, without needing that extra surgery.

Researchers will also be carefully checking for any side effects from the treatment, how well the main cancer lump is controlled, whether the cancer spreads to other parts of the body, and how long people live or stay free from cancer. They will also look at your quality of life, which means how the treatment affects your daily activities and general well-being. This information will help doctors understand if this new approach could become a standard treatment in the future.

Key takeaways

This study is for head and neck cancer that hasn't been treated before.
It combines standard radiotherapy with a drug called durvalumab (IMFINZI).
The main aim is to see if this combination can control cancer in the neck without needing surgery there.
Researchers will also track side effects and how people feel.
It's a Phase II study, an early step in testing new treatments.
Participation involves regular hospital visits for treatment and check-ups over two years.

Who may be eligible?

To be part of this study, you need to be an adult, 18 years or older, with a recent diagnosis of untreated squamous cell carcinoma in your head and neck.

Both men and women can take part. The research team will need to check other details about your health to make sure the study treatment is suitable and safe for you. They will explain all the specific requirements in detail.

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 old or older?
Have you been diagnosed with squamous cell carcinoma of the head and neck?
Have you not received any treatment for this cancer yet?
Are you comfortable with regular hospital visits and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive standard radiotherapy treatment combined with the durvalumab (IMFINZI) drug, given as an infusion. You would have regular appointments for treatment, medical check-ups, and to complete questionnaires about your health and how you are feeling. Doctors and nurses will monitor you closely for any side effects. These assessments will happen at specific times: before you start treatment, at 3 months, 12 months, and 24 months after your radiotherapy finishes. The total duration of your active participation, including follow-up, would be at least two years.

Potential risks and benefits

Taking part in a clinical trial might offer potential benefits, such as receiving a new or cutting-edge treatment that isn't widely available yet, and you'll be closely monitored by a dedicated medical team. However, there are also potential risks, including side effects from the new drug or the combination treatment, some of which might be serious. Because this is a research study, we don't yet know all the effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual 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
France

Common questions

What is durvalumab (IMFINZI)?

Durvalumab is a drug that helps your body's immune system fight cancer. It's given as a drip into your arm.

What does 'untreated' mean in this study?

It means you haven't received any prior treatment for your head and neck cancer before joining this study.

Will I still have radiotherapy if I join?

Yes, you will still receive radiotherapy as part of the treatment plan in this study.

What kind of side effects might there be?

The study will carefully monitor for any side effects. Your care team will explain common ones, and they will check if new or unexpected side effects happen.

How long will I be involved in the study?

You'll be followed up for at least two years after your treatment finishes to see how you're doing.