RecruitingOBSERVATIONAL

The RESCUE Study: Survival and Functional Outcomes Following Salvage Surgery for RESidual or reCurrent sqUamous cEll Carcinoma of the Head and Neck

The RESCUE study is researching people who have had surgery for head and neck cancer that has either reappeared, didn't fully go away, or is a new cancer in the same area. The study aims to understand how successful this surgery is, looking at how long people live and their day-to-day abilities afterwards. It also involves a closer look at the cancer's genes for some patients. This genetic part helps researchers understand if previous radiation treatment or a person's unique genes play a role in why the cancer came back. The study hopes to improve future treatments for head and neck cancer.

At a glance

Status

Recruiting

Sponsor

Royal Marsden NHS Foundation Trust

Enrolment target

400

Start

08 Sep 2023

Estimated completion

30 Apr 2029

Head and Neck Cancer

What is this study about?

The RESCUE study is looking into an important area of head and neck cancer care. Sometimes, head and neck cancer can come back, not fully go away after initial treatment, or a new cancer can develop in the same region. When this happens, doctors sometimes recommend 'salvage surgery' – an operation to remove the cancer again. This study wants to understand how effective this surgery is for patients.

Researchers will be looking at two main things. First, they want to see how people recover and their overall health after this type of surgery. This includes understanding how long patients live and how well they can do daily activities like eating and speaking. Second, for some patients who agree, the study will examine the cancer tissue at a very detailed level, looking at its genetic makeup. This is known as 'molecular analysis'.

By combining information about patient outcomes with detailed genetic insights, the RESCUE study aims to learn why some cancers return and others don't, especially after previous treatments like radiotherapy. The goal is to gather knowledge that could help doctors make better treatment decisions in the future and improve the lives of people facing recurrent head and neck cancer.

Key takeaways

The RESCUE study aims to improve understanding of head and neck cancer that returns.
It focuses on patients having additional surgery (salvage surgery) after previous treatment.
Researchers will look at how well patients recover and their quality of life.
For some, they'll also study the cancer's genes to see links with previous radiotherapy.
Your medical records and existing tissue samples (if applicable) are used, not extra tests.
Participation helps researchers find better treatments for future patients.

Who may be eligible?

To be part of this study, you would need to be over 18 years old. You should have previously had head and neck cancer that was treated with radiotherapy (which might have also included chemotherapy).

The cancer being studied is a specific type called squamous cell carcinoma, which has either come back, wasn't fully removed, or is a new cancer in your mouth, throat, or voice box area.

There are also reasons why someone might not be able to join. For example, if your head and neck cancer is in certain areas like the nose or skin, or if it's a different type of cancer (not squamous cell carcinoma), you wouldn't be eligible. Also, if the cancer has spread to distant parts of your body or is too advanced for surgery, you wouldn't be able to participate.

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 over 18 years old?
Have you had head and neck cancer (squamous cell carcinoma) treated with radiotherapy before?
Has your head and neck cancer come back, not fully gone, or is it a new cancer in related areas?
Is your cancer limited to the head and neck area (not spread far away)?
Is your specific type of head and neck cancer not in your nose, skin, or a non-squamous cell type?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the RESCUE study, your involvement would mainly revolve around the information gathered from your medical records related to your salvage surgery for head and neck cancer. This is because the study is looking at patient experiences and outcomes. If you consent to the 'molecular analysis' part, this would involve researchers studying a sample of your cancer tissue, likely taken during your surgery. There are no additional visits, medication, or specific procedures beyond your standard medical care for this study. The total duration of your participation would depend on how long the researchers track patient outcomes, but it wouldn't involve extra effort from you once your initial consent and data collection are done.

Potential risks and benefits

Participating in the RESCUE study typically involves very low risk as it primarily uses information from your medical records and, if you agree, a tissue sample from your surgery (which would have been removed anyway). For the molecular analysis, there's always a small chance of a data breach, though strict measures are taken to protect your privacy. There is no direct personal benefit from taking part, as the study aims to improve understanding for future patients. However, you would be contributing valuable information that could help improve future treatments and care for others with head and neck cancer. Remember, joining is entirely voluntary, and you have the right to withdraw your consent at any time without affecting your medical care.

Locations (9)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University Hospitals Derby and Burton
Verified postcode
Derby, United Kingdom· Recruiting
NHS Lothian
Verified postcode
Edinburgh, United Kingdom· Recruiting
Western General, Greater Glasgow and Clyde
Verified postcode
Glasgow, United Kingdom· Recruiting
Aintree Hospital
Verified postcode
Liverpool, United Kingdom· Recruiting
Head and Neck Unit, Royal Marsden Hospital
Verified postcode
London, United Kingdom· Recruiting
Northwick Park
Verified postcode
London, United Kingdom· Recruiting
Oxford University Hospital NHS Foundation Trust
Verified postcode
Oxford, United Kingdom· Recruiting
Poole Hospital, University Hospitals Dorset
Verified postcode
Poole, United Kingdom· Recruiting
South Tyneside and Sunderland NHS Foundation Trust
Verified postcode
Sunderland, United Kingdom· Completed

Common questions

What kind of cancer is this study about?

It's about squamous cell carcinoma, a common type of head and neck cancer.

What does 'salvage surgery' mean?

It's surgery done when head and neck cancer has returned, not fully disappeared, or is a new cancer after previous treatment.

Will I have extra tests or appointments if I join?

No, this study uses information from your existing medical records and, if you agree, a tissue sample from your surgery. There are no extra tests or appointments.

What is 'molecular analysis'?

It's a detailed look at the cancer's genes to understand why it might have returned, especially after radiotherapy.

Will taking part affect my medical treatment?

No, your decision to join or not join will not affect the medical care you receive.

How to find out more

Andrew Williamson

andrew.williamson2@rmh.nhs.uk 02073528171 Official trial record

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