EORTC 2120-HNCG: Radiotherapy plus xevinapant or placebo in older patients with locally advanced head and neck squamous cell carcinoma: a randomized phase II study (Ravina)
This research study, called Ravina, is investigating a new treatment approach for older patients with locally advanced head and neck squamous cell carcinoma. This is a type of cancer that starts in the moist linings of the head and neck, such as the mouth or throat. The study is comparing standard radiotherapy with radiotherapy combined with a new drug called xevinapant, or a placebo (a dummy drug). The main goal is to find out if adding xevinapant helps prevent the cancer from returning in the treated area or nearby, or from spreading. We'll also be looking at how long people live, how well the treatment shrinks the cancer, and any side effects. This is a Phase II study, which means we're carefully testing the drug's effectiveness and safety in a group of patients.
At a glance
What is this study about?
This research study, known as Ravina, is looking into new ways to treat a type of cancer called squamous cell carcinoma that affects the head and neck area. This cancer typically starts in the moist, flat cells lining the mouth, throat, or voice box. When the cancer is 'locally advanced,' it means it has grown into nearby tissues but hasn't spread to distant parts of the body.
The study involves older patients and aims to see if a new medication called xevinapant, when given alongside standard radiotherapy, can improve treatment outcomes. Radiotherapy uses high-energy rays to kill cancer cells. The main thing we're trying to find out is if the combination of xevinapant and radiotherapy can help patients live longer without the cancer coming back in the treated area. The study also looks at how well the treatment shrinks the cancer, how long people live overall, and any side effects people might experience.
This is a 'Phase II' study, which means it's an early-stage study focusing on whether the new drug works well and is safe enough to be tested in larger groups of patients. We're also checking how the treatment might affect patients' quality of life, including things like their general health, physical abilities, energy levels, and any pain.
Key takeaways
- This study explores a new drug called xevinapant for head and neck cancer.
- It combines xevinapant or a placebo with standard radiotherapy.
- The main goal is to prevent cancer from returning and improve survival.
- It's for older patients with locally advanced head and neck cancer.
- Participation involves regular hospital visits for treatment and check-ups.
Who may be eligible?
To join this study, you would generally need to have locally advanced squamous cell carcinoma of the head and neck. This means your cancer has spread to nearby tissues but not to other parts of your body. The study is open to both men and women.
There are no specific age limits mentioned, meaning that doctors will assess each patient individually to decide if the study is right for them, regardless of their exact age. The most important thing is that you and your doctor agree that this study might be a suitable option for your unique situation.
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.
- Do I have locally advanced squamous cell carcinoma of the head and neck?
- Am I able to receive radiotherapy for my cancer?
- Am I open to receiving a new experimental drug or a placebo?
- Am I willing to attend regular hospital appointments and provide health information?
What does participation involve?
If you decide to participate in this study, you will either receive radiotherapy combined with the new drug xevinapant, or radiotherapy combined with a placebo (a dummy drug that looks like xevinapant but contains no active medicine). You won't know which one you are receiving. You'll have regular hospital visits for your radiotherapy treatments and to receive either xevinapant or the placebo. During these visits, the study team will carry out health checks, blood tests, and scans to monitor your progress and check for any side effects. You'll also be asked to complete questionnaires about your quality of life. The study team will explain exactly what's involved in your specific case, including how often you'll need to visit and for how long. There will be follow-up appointments after your treatment finishes to continue monitoring your health.
Potential risks and benefits
Locations (9)
- —UnverifiedItaly
- —UnverifiedSlovenia
- —UnverifiedGermany
- —UnverifiedNetherlands
- —UnverifiedBelgium
- —UnverifiedNorway
- —UnverifiedSpain
- —UnverifiedFrance
- —UnverifiedIreland
Common questions
What is squamous cell carcinoma of the head and neck?
It's a type of cancer that starts in the flat, moist cells lining parts of your head and neck, like your mouth or throat.
What is xevinapant?
It's a new drug being tested to see if it can help improve treatment for head and neck cancer when given with radiotherapy.
What does 'Phase II study' mean?
It means this is an early stage of testing, to see if a new treatment works well and is safe enough to be studied in more people.
What is a 'placebo'?
A placebo is adummy drug that looks like the real medicine but contains no active ingredients. It helps us fairly compare the new drug's effects.
Will I know if I'm getting the drug or the placebo?
No, you won't know, and neither will your doctors. This is called a 'blinded' study and helps ensure the results are accurate.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.