JNJ-90301900 (NBTXR3) activated by radiotherapy with or without cetuximab in LA-HNSCC
This study is investigating a new treatment, JNJ-90301900, which is activated by radiotherapy. Some participants will also receive cetuximab. It's for patients with advanced head and neck cancer that started in areas like the mouth or throat. The study is specifically for those aged 60 and over who are not suitable for standard platinum-based chemotherapy due to other health reasons or age. Researchers want to see how safe and effective this new approach is compared to radiotherapy alone or with cetuximab. It’s important because it aims to find better options for a group of patients who currently have limited treatment choices while keeping them comfortable.
At a glance
What is this study about?
This study is designed for older individuals, 60 years or above, who have a type of advanced head and neck cancer. This cancer can appear in places like the mouth, throat, or voice box. Often, the main treatment involves radiotherapy, sometimes with chemotherapy. However, some people can't have chemotherapy because of other health issues, such as problems with their kidneys or heart, or simply due to their age.
This research is looking at a new treatment called JNJ-90301900. This special substance is placed directly into the tumour and then activated by the radiotherapy. The idea is that it could make the radiotherapy more effective. Some patients in the study will receive this new treatment along with their radiotherapy, while others might also get another drug called cetuximab.
The main goal of the study is to see if JNJ-90301900, when used with radiotherapy (with or without cetuximab), is a safe and effective option for these patients. It's a 'Phase 3' study, which means it's one of the final steps in testing a new treatment, comparing it to existing approaches to see if it’s better. The hope is to find a useful new treatment for those who can't have the usual chemotherapy options.
Key takeaways
- It's for advanced head and neck cancer.
- Ages 60+ and unable to have standard chemotherapy.
- Tests a new treatment with radiotherapy.
- May involve another drug, cetuximab.
- Aims for better options for this patient group.
Who may be eligible?
This study is particularly looking for people aged 60 or older who have a specific type of head and neck cancer in areas like the mouth or throat. You would need to be suitable to receive radiotherapy, with or without a drug called cetuximab. A key part of qualifying is that your cancer should be at a certain advanced stage, and the tumour they would treat needs to be in a place where they can inject the study drug directly into it.
Critically, you must also be unable to have standard chemotherapy. This could be for several reasons, such as kidney problems, significant hearing loss, nerve damage, or if you have certain heart conditions. People aged 70 or older are also considered if they meet specific health assessments. It’s about finding a safer alternative for those who can't tolerate the usual strong chemotherapy drugs.
However, some people would not be able to join. For example, if your head and neck cancer is in the nose, salivary glands, or thyroid. If you’ve already had surgery, radiotherapy, or chemotherapy for this head and neck cancer that has come back, this study isn't for you. Also, if you have other types of cancer or active infections needing treatment, you might not be eligible.
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 60 years old or older?
- Do you have head and neck cancer in the mouth, throat, or voice box?
- Has your doctor told you that your cancer is at a more advanced stage?
- Have you been told you cannot receive standard chemotherapy?
- Is your main tumour in a place where an injection could be given?
What does participation involve?
Taking part in this study would involve having the new treatment, JNJ-90301900, injected into your tumour, followed by radiotherapy, which you would receive as usual. Some patients might also receive cetuximab. You would have regular check-ups and tests throughout your treatment period to monitor your health and the effects of the treatment. The total length of the study, including follow-up appointments after your main treatment, isn't specified but typically involves monitoring your progress for some time after treatment finishes.
Potential risks and benefits
Locations (1)
- -Approximate-, England
Common questions
What kind of head and neck cancer is this study for?
It's for squamous cell carcinoma that starts in areas like the mouth, throat, or voice box, specifically when it's at an advanced stage.
Why is this study only for older patients?
It focuses on patients aged 60 and over, especially those who can't receive standard chemotherapy due to other health issues or age-related concerns.
What is JNJ-90301900?
It's a new substance that's injected into the tumour and is designed to boost the effects of radiotherapy.
Will I definitely get the new treatment?
Participants will be assigned to different treatment groups, so you might receive the new treatment plus radiotherapy, or radiotherapy with cetuximab, or just radiotherapy, depending on the study design.
Can I leave the study if I change my mind?
Yes, you can choose to leave the study at any time, and it won't affect your medical care.
How to find out more
Lynda McSorley
Always speak to your GP or specialist before deciding to take part in a study.
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