RecruitingNAINTERVENTIONAL

Partial Volume High-Dose Irradiation in Renal Cell Carcinoma for Intra-TUmoural Control ALongside Current Management

This study, called ‘Partial Volume High-Dose Irradiation in Renal Cell Carcinoma’, is for people with kidney cancer (Renal Cell Carcinoma), whether it's localised or has spread to other parts of the body. We want to see if a newer, shorter course of radiotherapy, given in five sessions, is as good and safe as the standard course, which is given in ten sessions. Both courses deliver the same total amount of radiation, just in different ways. This research aims to understand if offering this shorter, more concentrated treatment is practical and effective. It's a key step to see if this treatment could become a standard option in the future, potentially making treatment less burdensome for patients while still achieving good results.

At a glance

Status

Recruiting

Phase

Sponsor

Royal Marsden NHS Foundation Trust

Enrolment target

Start

27 Mar 2023

Estimated completion

01 May 2026

Renal Cell Carcinoma Renal Cell Carcinoma Metastatic

What is this study about?

This research is focused on kidney cancer, also known as Renal Cell Carcinoma (RCC). We know that cancer treatment can be tough, and doctors are always looking for ways to make it more effective and easier for patients. This particular study is investigating a type of treatment called radiotherapy, which uses high-energy beams to destroy cancer cells.

Currently, for some kidney cancer patients, radiotherapy is given in ten daily sessions over two weeks. This study wants to compare that standard approach with a new, ‘high-dose, hypofractionated’ radiotherapy. This new method delivers the same total amount of radiation but in just five sessions, given every other day over two weeks. The idea behind this is to see if a shorter, more intense course of treatment works as well, has similar side effects, and is practical for patients and hospitals.

The main goal right now isn't to prove that one treatment is better than the other in terms of curing the cancer. Instead, it's a 'feasibility study'. This means we're trying to find out if it's realistic and safe to run a larger study later on. We'll be looking closely at how patients react to both treatments, including any side effects, and how it impacts their quality of life. The information from this study will be very important for deciding if this new way of delivering radiotherapy has a future in treating kidney cancer.

Key takeaways

This study compares two ways of giving radiotherapy for kidney cancer.
It's for people with localised or spread kidney cancer who can't have surgery.
One group gets standard radiotherapy (10 sessions), the other gets a new shorter version (5 sessions).
The main aim is to see if the shorter treatment is practical and safe.
Participants will have regular check-ups and fill out quality of life questionnaires.
You can withdraw from the study at any time without affecting your care.

Who may be eligible?

You might be able to take part in this study if you have kidney cancer (Renal Cell Carcinoma), whether it’s in one area or has spread. This study is for you if surgery or other treatments like tumour removal aren't suitable for your particular situation. The cancer can be in any part of your body except for inside your brain, if that area needs radiotherapy.

There are also some general health requirements. You need to be at least 18 years old and generally well enough to manage the treatment. Doctors will check your overall health, including blood tests and how well your organs are working, to make sure it's safe for you to participate. You also need to be able to understand what's involved and give your consent to take part.

However, you wouldn't be able to join if your doctors expect your prognosis to be less than six months, or if your cancer has spread to your brain and isn't under control. Also, if you've had radiotherapy before to the same area, or if you have other serious health problems or are pregnant/breastfeeding, this study might not be right for you.

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 you have kidney cancer (Renal Cell Carcinoma)?
Is surgery or a similar treatment not suitable for your cancer?
Are you 18 years old or over?
Are you generally well enough to receive radiotherapy?
Could you attend study appointments for up to 12 months?
Are you not currently pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned by chance (like flipping a coin) to one of two treatment groups: either the standard radiotherapy (10 sessions) or the new high-dose radiotherapy (5 sessions). You and your doctors will know which treatment you're receiving.

Before treatment starts, you'll have an appointment to discuss everything, and then a CT scan to plan your radiotherapy. During treatment, you'll have either 10 appointments (standard group) or 5 appointments (new group) for your radiotherapy over two weeks. You'll also have two quick check-ups with the clinic during this time.

After your radiotherapy finishes, there will be a safety check-up about four weeks later. Following that, you'll have follow-up appointments at 3 months, 6 months, and 12 months. Throughout the study, you'll be asked to complete questionnaires about your quality of life, and you'll also have blood tests and physical examinations as part of your regular care. The total duration of active follow-up for the study is 12 months.

Potential risks and benefits

Potential benefits of participating could include receiving a treatment that might be more convenient (fewer sessions) while maintaining effectiveness, which could improve your quality of life during treatment. However, it's also possible that the new high-dose treatment might have different or perhaps more intense side effects, though the study aims to carefully monitor these. As with any medical treatment, there are always potential risks, and the research team will explain all known risks specific to radiotherapy. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

The Royal Marsden NHSFT
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is Renal Cell Carcinoma?

Renal Cell Carcinoma is the most common type of kidney cancer. This study is for people diagnosed with this condition.

What is 'radiotherapy'?

Radiotherapy is a cancer treatment that uses high-energy beams, similar to X-rays, to accurately destroy cancer cells or stop them from growing.

What does 'high-dose hypofractionated' mean?

It means delivering the total required radiation dose in larger amounts (high-dose) over fewer treatment sessions (hypofractionated) compared to the standard approach.

Will I know which treatment I'm getting?

Yes, both you and your medical team will know whether you are receiving the standard radiotherapy or the new high-dose radiotherapy. This study isn't 'blinded'.

What does a 'feasibility study' mean?

A feasibility study checks if it's practical and safe to carry out a new medical approach before committing to a much larger, more expensive study. It helps us understand if the new treatment has potential.

How to find out more

Harshani Green

VIRTUAL.Trial@rmh.nhs.uk 020 7811 8116 Official trial record

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