RecruitingOBSERVATIONAL

Single and Combined Modality Trans-Oral Robotic Surgery in Early Oropharyngeal Cancer

This study, called SCORE, is looking at people who had a specific surgery called Trans-Oral Robotic Surgery (TORS) for early head and neck cancer. This surgery removes cancer through the mouth. The main goal is to find out how well patients recover and if the cancer comes back. Researchers are also trying to understand if certain features, seen on scans or in genetic material from the cancer, can help predict who might do better or worse. The study also aims to figure out the safest amount of healthy tissue to remove around the cancer during surgery to reduce the chance of it returning. They're also checking how often patients have problems soon after surgery. This information will help doctors improve care for future patients.

At a glance

Status

Recruiting

Sponsor

Royal Marsden NHS Foundation Trust

Enrolment target

250

Start

19 Dec 2023

Estimated completion

01 Aug 2027

Cancer Head Neck

What is this study about?

Imagine a special type of surgery that removes cancer from the back of the mouth and throat through the mouth itself, using tiny robots. This is called Trans-Oral Robotic Surgery (TORS). This study, known as SCORE, is looking back at many people across different hospitals who have already had this surgery for early-stage head and neck cancer. The main goal is to understand how well they recovered and if the cancer came back over time.

The researchers are particularly interested in seeing if there's a certain amount of healthy tissue that needs to be removed around the cancer during surgery to make sure it doesn't return. They are also examining how often people had problems straight after their operation. For some patients, they are also studying previous scans or looking at genetic information from their cancer to see if these can give clues about how the cancer might behave and who might benefit from extra treatments after surgery.

Ultimately, this study aims to gather important information that can help doctors make better decisions about treatment for future patients with early head and neck cancer. By understanding what worked well and what didn't for past patients, they hope to improve care and reduce the chances of cancer coming back.

Key takeaways

This study helps understand the best treatment for early head and neck cancer.
It uses information from past Trans-Oral Robotic Surgery (TORS) patients.
Researchers are looking at treatment success, complications, and cancer recurrence.
Data from older scans and tissue samples may help predict treatment outcomes.
The study aims to improve care for future patients with similar cancers.

Who may be eligible?

This study is looking at information from people who have already had treatment for a specific type of head and neck cancer. You would be included if you were 18 years or older at the time of your surgery, and your cancer was in specific areas of the throat like the tonsils or back of the tongue. It must have been confirmed as squamous cell carcinoma by a biopsy.

Your cancer needed to be an early stage (T1 or T2) and treated with Trans-Oral Robotic Surgery (TORS), either on its own or with other treatments like radiotherapy. The surgery must have taken place on or before 31st December 2021. If your cancer was more advanced, or if the TORS was done to check for cancer, treat recurring cancer, or for comfort care, you would not be included.

Also, if you had a history of other head and neck cancers or radiotherapy to that area before, or if your cancer had spread to distant parts of your body, you wouldn't be part of this study. This study is focused only on this specific type of head and neck cancer.

Quick self-check

I was 18 or older when I had my surgery.
My cancer was in the tonsils, back of the tongue, or other specific parts of the throat.
It was diagnosed as squamous cell carcinoma and was early stage (T1 or T2).
I had Trans-Oral Robotic Surgery (TORS) for this cancer on or before December 31, 2021.
I have not had other head and neck cancers or radiation to that area before.

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

Since this is mostly a study looking back at existing medical records, if your information is included, you likely won't need to do anything extra. The researchers will review your past medical notes and scans. For some specific parts of the study (only in the UK), if you previously agreed, your stored tissue samples from surgery might be used for genetic analysis. You won't need to visit the hospital specifically for the study or take any new medications. The total duration of your involvement would be limited to the time it takes for researchers to review your existing health information.

Potential risks and benefits

Because this study primarily involves reviewing existing medical records and, in some cases, stored tissue samples, there are generally no direct risks to you as a patient. Your personal information will be kept confidential. The main benefit is that the information from your treatment journey will help doctors learn more about the best ways to treat early head and neck cancer, potentially improving care for future patients. You have the right to withdraw your consent for your data or samples to be used if you previously agreed, and this would not affect your medical care.

Locations (1)

The Royal Marsden Hospital NHS Foundation Trust
London, United Kingdom· Recruiting

Common questions

What kind of cancer is this study about?

It's about early-stage squamous cell carcinoma, a type of cancer that affects specific parts of the throat and mouth, like the tonsils or base of the tongue.

What is Trans-Oral Robotic Surgery (TORS)?

It's a surgery where doctors use special robotic tools to remove cancer from your mouth and throat through your mouth, without making an incision on your neck.

Do I need to do anything if I'm in this study?

Not usually. This study mostly uses information from your past medical records and, if you agreed previously, old tissue samples from your surgery.

Will this study change my current medical care?

No, this study looks at past information and won't affect any ongoing or future medical care you receive.

What will researchers learn from this study?

They hope to understand how successful TORS is for this cancer, what causes complications, and if scans or genetic tests can help predict who needs more treatment, making care better for future patients.

How to find out more

Andrew Williamson

andrew.williamson2@rmh.nhs.uk 02000000000 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.