At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Radiotherapy dose escalation (radiation)
- How long the study runs
- Study runs about 47 months (dates as stated)
- About the drug or intervention
- Radiotherapy dose escalation — radiation: All patients will receive 45Gy in 25# to mesorectum and elective nodal volumes, and 52.5Gy in 25# as standard to primary gross tumour volume which includes primary tumour, visible nodal disease and extramural vascular invasion if present.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, run by the Royal Marsden NHS Foundation Trust, is looking at higher-dose radiotherapy for rectal cancer using a machine called an MR-Linac, which combines an MRI (magnetic resonance imaging) scanner with a radiotherapy machine. It is for people with locally advanced rectal adenocarcinoma (a type of bowel cancer) who need chemoradiotherapy (chemotherapy plus radiotherapy) before surgery or other treatment.
Who can take part
- Adults aged 18 or over
- Rectal adenocarcinoma confirmed by tests, needing chemoradiotherapy before main treatment
- Able to have chemotherapy at the same time as radiotherapy
- Cancer fits within the treatment area of the MR-Linac machine
- Fairly well and active (World Health Organization performance status 0 to 2)
- Able to understand and sign a consent form
- Willing to fill in questionnaires about how they feel during the study
Who may not be able to
- Unable to have an MRI scan, for example due to a pacemaker, certain metal implants, or severe claustrophobia
- Cancer is larger than the maximum treatment area
- Other health problems that could cause serious side effects, such as inflammatory bowel disease, or that make long-term follow-up impossible
- Hip replacements or other metal implants in the pelvis that affect scan pictures
- Radiotherapy to the pelvis in the past
- Need chemotherapy before starting chemoradiotherapy
- Another invasive cancer in the last 2 years, apart from some skin cancers, low-risk bladder cancer, or small kidney tumours being monitored
What taking part involves
- • Radiotherapy given at a higher dose using an MR-Linac machine (an MRI scanner combined with a radiotherapy machine)
- • Chemotherapy given at the same time as radiotherapy
- • Filling in questionnaires about how you feel throughout the study
Time commitment: Taking part involves chemoradiotherapy on the MR-Linac and completing questionnaires during the study; the number of visits and total duration are Not stated — ask the trial team.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 13
- Started
- 2025-02-14
- Last checked
- 2024-12
Plain English Summary
What is this study?
- • Testing a new treatment for rectal adenocarcinoma
- • NA - 13 participants
- • Standard radiotherapy in the UK involves having daily chemotherapy tablets with radiotherapy treatment for 5 weeks at a dose of 52
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with rectal adenocarcinoma
Where?
- • Sutton - The Royal Marsden Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Standard radiotherapy in the UK involves having daily chemotherapy tablets with radiotherapy treatment for 5 weeks at a dose of 52.5Gy to the rectal cancer over 25 fractions. This is the likely treatment participants will be having if they decide not to take part in this study. Increasing the dose to 60Gy is shown to increase the chance that rectal cancer will be treated completely, a term known as "complete pathological response". Patients who have a complete pathological response after their treatment can avoid surgery and enter into a surveillance programme to monitor for early signs of the cancer returning. Surveillance can mean 3-6 months camera tests and MRI scans depending on the local unit. If these patients continue to show signs of complete pathological response then they can avoid long term complications from surgery such as a stoma. Unit studies have shown that that increasing the dose of radiotherapy can cause slightly more bowel and bladder side effects, but using adaptive radiotherapy to limit radiotherapy to normal tissue could keep the rate of bothersome side effects as low, which is similar as standard treatment. All adaptive treatments within this trial will be delivered on a state of the art, radiotherapy machine called an MR-linac (Magnetic Resonance Linear Accelerator). It combines an MRI scanner with a radiotherapy treatment machine called a Linear Accelerator (called a 'linac' for short). The use of the MR-linac means there is no extra radiation dose given when taking daily images to check for the position of participants rectal cancer (unlike CT scans or X-ray). It also enables the investigators to adapt or 'tweak' the radiotherapy plan each day to match the exact position of the rectal cancer and adjacent organs. The non-adaptive fractions can be delivered on either the MR-Linac or CT-linac depending on factors such as treatment machine availability. The investigators will deliver the treatment on the MR-linac using a technique called intensity modulated radiotherapy (precise X-ray treatment, called IMRT for short). IMRT is able to mould radiotherapy treatment according to what the investigators can see, therefore enabling the investigators to give highly targeted treatment. The investigators already have considerable experience in delivering radiotherapy to rectal cancer with this machine and now wish to focus on whether they could increase dose to benefit long term outcome for all rectal cancer patients as well as reducing the side effects of treatment. The purpose of this research is to increase the dose to rectal cancer while adapting to the changes that the investigators can see to the rectal cancer during treatment. This means that if the rectal cancer is seen to reduce in size they will be able to deliver a 'shrinking boost' according to what can be seen. This will enable the investigators to give high dose radiotherapy to the cancer whilst limiting radiotherapy to healthy tissue. Without the ability to adapt to changes that the investigators see to the tumour throughout the entire treatment course, standard treatment delivers dose to a larger area of surrounding healthy tissue to ensure that the tumour is sufficiently targeted. The investigators want to find out if by using this adaptive, shrinking boost approach, they can safely increase radiotherapy dose to rectal cancer, whilst limiting the side effects you experience, in comparison with standard treatment. If this is possible, then this would lead into further clinical trial where the investigators would compare outcomes of higher-dose treatment to standard-of-care. The investigators can't be certain that the side effects will be different, and they don't know if this treatment results in the best chance of cancer cure. However they know from other studies that this is the likely outcome, with surgery being delayed for patients. Patients who have a complete pathological response after combined chemotherapy and radiotherapy treatment enter into a surveillance programme where MRI and camera tests (flexible sigmoidoscopy) are performed at regular intervals looking for early signs of cancer returning. The investigators expect that the chance of participants having a complete pathological response with this technique is higher than with standard dose, although the investigators can't know this for sure until they have completed further studies. It is possible that the cure rate may be lower or higher than the standard dose.
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓All patients aged ≥18 years
- ✓Histological confirmation of that has grown locally rectal adenocarcinoma requiring before surgery chemoradiotherapy as per...
- ✓Patients suitable for concomitant drug treatment
- ✓Patients with disease included within treatment field size of MR-Linac.
- ✓WHO Performance status 0-2
Who cannot take part
- ✗Contraindications to MRI (e.g. pacemaker, potentially mobile metal implant, claustrophobia)
- ✗Disease outside maximum radiotherapy treatment field length.
- ✗other health conditions which predispose to significant toxicity (e.g. inflammatory bowel disease) or preclude long term follow up
- ✗Unilateral or bilateral total hip replacement, or other pelvic metalwork which causes artefact on diffusion-weighted...
- ✗Previous pelvic radiotherapy
See the full criteria
Where Is This Study? (1 UK site)
The Royal Marsden Hospital
Sutton SM2 5PT, United Kingdom
How to Get in Touch
Brian Hin, FRCR MD(res)
Sponsor contactCONTACT