Rectal AdenocarcinomaANDROMEDANCT06854679
Dose Escalated Radiotherapy for Rectal Cancers Using MR-guided Radiotherapy
A study testing Radiotherapy dose escalation in people with Rectal Adenocarcinoma, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Adenocarcinoma
- What is being tested?
- Radiotherapy dose escalation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Feb 2025to 13 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients aged ≥18 years
- Histological confirmation of locally advanced rectal adenocarcinoma requiring neoadjuvant chemoradiotherapy as per RMH clinical guidelines.
- Patients suitable for concomitant chemotherapy
- Patients with disease included within treatment field size of MR-Linac.
- WHO Performance status 0-2
- Ability of the participant understand and the willingness to sign a written informed consent form.
- Ability/willingness to comply with the patient reported outcome questionnaires schedule throughout the study.
Who cannot join
- Contraindications to MRI (e.g. pacemaker, potentially mobile metal implant, claustrophobia)
- Disease outside maximum radiotherapy treatment field length.
- Comorbidities 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 imaging
- Previous pelvic radiotherapy
- Patients needing induction chemotherapy prior to chemoradiotherapy
- Previous invasive malignancy within the last 2 years excluding basal or squamous cell carcinomas of the skin, low risk non-muscle invasive bladder cancer (assuming cystoscopic follow up now negative) or small renal masses on surveillance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
The Royal Marsden Hospital
Sutton, Surrey, SM2 5PT
Francesca Mason, 0208 642 6011, francesca.mason@rmh.nhs.uk
About this study
Official title: A Feasibility Study in Dose Escalated Treatment in Rectal Cancer on Mr-Linac Using Mr GuidED Adaptive Radiotherapy
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.
Read more
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.
- Conditions
- Rectal Adenocarcinoma
- Being tested
- Radiotherapy dose escalation
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiotherapy dose escalationRadiation
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. Boost dose escalation to a maximum of 60Gy will be delivered to patients with ongoing visible disease from week 2 of treatment onwards.
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy dose escalation | Experimental | 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. Boost dose escalation to a maximum of 60Gy will be delivered to patients with ongoing visible disease from week 2 of treatment onwards. Receives: Radiation: Radiotherapy dose escalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients completing 90% or more fractions delivered on MR-Linac.
To establish the technical feasibility of delivering adaptive dose escalated radiotherapy on an MR-Linac.
Measured: Up to 12 weeks
Secondary outcomes (5)
• Physician reported gastrointestinal (GI) and genitourinary (GU) toxicity (CTCAE grade) at baseline and the end of treatment then at 6 and 12 weeks post-treatment.
- Physician reported gastrointestinal (GI) and genitourinary (GU) toxicity (CTCAE grade) at baseline and the end of treatment then at 6 and 12 weeks post-treatment.
Measured: 24 months post completing treatment
• Late toxicity (CTCAE) at 1 and 2 years post-treatment.
- Late toxicity (CTCAE) at 1 and 2 years post-treatment.
Measured: 24 months post completing treatment
• Recurrence/progression assessment for up to 2 years following completion of treatment.
- Recurrence/progression assessment for up to 2 years following completion of treatment.
Measured: 24 months post completing treatment
• Post-treatment pathological response assessment at 6 weeks with MRI using Mandard response grading. If complete pathological response on MRI then patient will undergo surgical surveillance with sigmoidoscopy and biopsy. If ongoing disease patient will
- Post-treatment pathological response assessment at 6 weeks with MRI using Mandard response grading. If complete pathological response on MRI then patient will undergo surgical surveillance with sigmoidoscopy and biopsy. If ongoing disease patient will have appropriate surgical technique for removal of tumour.
Measured: 24 months post completing treatment
• Patient-reported outcome measures (PROMs)
Patient-reported outcome measures (PROMs) from the QLQ-CR29 and QLQ-C30 questionnaires. Patients will be asked to complete PROMs at 6 and 12 weeks, 6 months, 1 and 2 years post treatment. Scale of 1(low impact) to 4 (high impact)
Measured: 24 months post completing treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start14 Feb 2025
- Primary completion13 Jan 2027 (estimated)
- Study completion13 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06854679
- Sponsor's protocol ID
- CCR 5774
- Acronym
- ANDROMEDA
- Status last verified
- Dec 2024
- First submitted
- 3 Dec 2024
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study in Dose Escalated Treatment in Rectal Cancer on Mr-Linac Using Mr GuidED Adaptive Radiotherapy
- ClinicalTrials.gov ID
- NCT06854679
- Acronym / sponsor ID
- ANDROMEDA / CCR 5774
- Conditions
- Rectal Adenocarcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- 14 Feb 2025 (actual)
- Primary completion
- 13 Jan 2027 (estimated)
- Study completion
- 13 Jan 2029 (estimated)
- First posted
- 3 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy dose escalation | Experimental | Radiation: Radiotherapy dose escalationAll 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. Boost dose escalation to a maximum of 60Gy will be delivered to patients with ongoing visible disease from week 2 of treatment onwards. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- All patients aged ≥18 years
- Histological confirmation of locally advanced rectal adenocarcinoma requiring neoadjuvant chemoradiotherapy as per RMH clinical guidelines.
- Patients suitable for concomitant chemotherapy
- Patients with disease included within treatment field size of MR-Linac.
- WHO Performance status 0-2
Key exclusion criteria (7 listed)
- Contraindications to MRI (e.g. pacemaker, potentially mobile metal implant, claustrophobia)
- Disease outside maximum radiotherapy treatment field length.
- Comorbidities 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 imaging
- Previous pelvic radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiotherapy dose escalationAll 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. Boost dose escalation to a maximum of 60Gy will be delivered to patients with ongoing visible disease from week 2 of treatment onwards. | Radiation | Radiotherapy dose escalation |
Primary outcome
Number of patients completing 90% or more fractions delivered on MR-Linac.
Time frame: Up to 12 weeks
To establish the technical feasibility of delivering adaptive dose escalated radiotherapy on an MR-Linac.
5 secondary outcomes
• Physician reported gastrointestinal (GI) and genitourinary (GU) toxicity (CTCAE grade) at baseline and the end of treatment then at 6 and 12 weeks post-treatment.
Time frame: 24 months post completing treatment
• Late toxicity (CTCAE) at 1 and 2 years post-treatment.
Time frame: 24 months post completing treatment
• Recurrence/progression assessment for up to 2 years following completion of treatment.
Time frame: 24 months post completing treatment
• Post-treatment pathological response assessment at 6 weeks with MRI using Mandard response grading. If complete pathological response on MRI then patient will undergo surgical surveillance with sigmoidoscopy and biopsy. If ongoing disease patient will
Time frame: 24 months post completing treatment
• Patient-reported outcome measures (PROMs)
Time frame: 24 months post completing treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiotherapy dose escalation in people with Rectal Adenocarcinoma, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brian Hin, FRCR MD(res) (extension 4228, brian.hin@rmh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients completing 90% or more fractions delivered on MR-Linac. (time frame: Up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2025.