p16+ Oropharyngeal Cancer Radiation Optimization Trial Reducing Elective Treatment Volumes (PROTEcT)
This study, called PROTEcT, is investigating a new treatment approach for squamous cell carcinoma of the oropharynx that tests positive for p16. This type of cancer is often found in the back of the throat, including areas like the tonsils. The main goal is to find out if we can give less intense radiation therapy to healthy areas of the neck, while still giving enough to the cancerous parts. This could mean fewer side effects for patients. The study involves a modified radiation plan and standard chemotherapy. It’s a multi-centre study, meaning several hospitals are taking part, and it's looking closely at patients who receive this particular treatment plan.
At a glance
What is this study about?
This study is called PROTEcT, which stands for p16+ Oropharyngeal Cancer Radiation Optimization Trial Reducing Elective Treatment Volumes. It’s looking into a specific type of throat cancer known as p16-positive oropharyngeal squamous cell carcinoma. This cancer affects the back of the throat, including areas like the tonsils, soft palate, and base of the tongue.
The main idea behind this study is to see if we can make radiation treatment for this cancer kinder to the body. Doctors are exploring if they can use slightly lower doses of radiation on healthy areas of the neck that are at risk, without making the treatment less effective at fighting the cancer. By doing this, they hope to reduce some of the common side effects that people experience during and after radiation therapy, like difficulty swallowing or a dry mouth.
Participants in the study will receive a specific radiation plan tailored to this new approach. They'll also receive chemotherapy alongside the radiation, using medicines like cisplatin or cetuximab, which are standard treatments. The study will carefully monitor patients to see how well this modified treatment works and how it affects their quality of life. This is a "single arm study," which means everyone in the study will receive this new combined treatment plan.
Key takeaways
- This study explores a modified radiation and chemotherapy approach for p16+ throat cancer.
- The main aim is to reduce treatment side effects by carefully adjusting radiation doses.
- It's a multi-centre study, meaning several UK hospitals are involved.
- Chemotherapy will be given alongside radiation, following standard guidelines.
- Participation involves a specific radiation plan, chemotherapy, and regular follow-up appointments.
Who may be eligible?
To be considered for this study, you need to be at least 18 years old and have been diagnosed with a p16-positive squamous cell carcinoma in your oropharynx (that's the back of your throat). The cancer should be at an early to moderate stage (T1-T3, N1-N2). You'll also need to be well enough to receive treatment that aims to cure your cancer, and your general health, including your blood, liver, and kidney functions, must be good enough to handle the chemotherapy.
There are also some reasons why you might not be able to join. For example, if your cancer has spread to other parts of your body, or if it has spread into a specific gland in the neck (called the submandibular gland), or if it extends into the mouth. You also can't have had radiation to your head and neck area before. If you're pregnant or breastfeeding, you won't be able to take part.
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?
- Do you have p16-positive throat cancer that hasn't spread widely?
- Are you generally well and able to undergo curative treatment?
- Have you not had previous radiation to your head and neck area?
- Are you not pregnant or breastfeeding?
What does participation involve?
If you decide to take part in this study, you will receive a specific type of radiation therapy for your throat cancer. This involves 30 daily radiation sessions over several weeks, targeting the tumour and nearby areas, with slightly lower doses to some healthy areas. You will also receive chemotherapy alongside the radiation, either every three weeks or weekly, depending on the drug chosen by your medical team. You will have regular appointments for check-ups and monitoring during and after your treatment to see how you are responding and to manage any side effects. The total duration of your involvement, including follow-up, will be discussed by your doctor.
Potential risks and benefits
Locations (1)
- Tom Baker Cancer CentreVerified postcodeCalgary, Canada· Recruiting
Common questions
What is p16-positive oropharyngeal cancer?
This is a type of throat cancer that tests positive for a specific protein called p16. This often means the cancer responds well to treatment.
What does 'de-intensified' treatment mean?
It means doctors are trying to use a slightly lower amount of radiation on healthy parts of your body, hoping to reduce side effects while still effectively treating the cancer.
Will I still receive chemotherapy?
Yes, you will receive chemotherapy alongside your radiation treatment, as is standard practice for this type of cancer.
How long will the radiation treatment last?
The radiation treatment itself will be given over 30 sessions, typically spread over several weeks.
What if I change my mind about participating?
You are free to leave the study at any time without it affecting your medical care.
How to find out more
Harvey Quon, MD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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