An interventional study of Radiotherapy to the spine in a single appointment in Metastatic Spinal Cord Compression, sponsored by The Christie NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-02.
Sponsored by The Christie NHS Foundation Trust · Not applicable, Interventional, and Supportive care
The goal of this clinical trial is to understand whether the Magnetic Resonance Linear Accelerator (MRL) could expedite Radiotherapy treatment for Metastatic Cord Compression (MSCC) by removing the need for a planning CT (pCT) scan prior to treatment. Radiotherapy will be delivered in one appointment on the MRL and compared to the standard of care of two appointments: a CT scan and a Radiotherapy appointment.
The main questions it aims to answer are:
Participants in both groups will receive the same prescription of 8Gray (Gy) in one treatment (fraction) delivered with one posterior-anterior beam as per our department policies and national standards.
Participants will be asked to complete an optional questionnaire prior to treatment to monitor the diversity of the study population. This questionnaire is anonymised, no personal data that could identify a participant is collected on this questionnaire.
After treatment participants will be asked to complete an experience questionnaire, to assess treatment experience.
Once the questionnaire is complete active participation in the trial is no longer needed, researchers will monitor participants notes for up to 12 months after treatment to record participant well being and function.
Metastatic cord compression occurs in 5-10% of patients with cancer often affected the ends stages of a patient's illness. The benefit of palliation is directly related to the speed of treatment, National Institute of Health and Care Excellence (NICE) guidelines recommend that radiotherapy is given within 24 hours of a decision to treat. A recent audit of the current referrals and pathway showed the average time from consultation to treatment is 2.10 days (SD 12.2 days). This audit concluded the need to improve the speed of access to care.
The current pathway includes a scan for diagnosis (MRI), a visit for a planning CT and time to plan the treatment before treatment delivery. This can take many hours or even days. To provide quicker access to care it is intended to use the MR Linac with an integrated adaptive radiotherapy platform, to deliver a scan, plan and treat model in a single appointment.
Preliminary work has modelled dose differences due to the presence of a magnetic field, known as the electron return effect and developed an MR only workflow using a simple planning technique to enable the online scan, plan and treat model.
The primary objective is to test the feasibility of a one-stop MR guided palliative radiotherapy programme for patients with MSCC.
Secondary objectives are:
This is a single centre, non-randomised clinical trial. All patients referred for radiotherapy to treat MSCC who can provide informed consent can be considered. Participants will be asked to have treatment on the MR Linac within a single appointment and complete an experience questionnaire. If participants would not like to have treatment on the MRL or do not meet the inclusion criteria participants can continue the standard of care pathway with the addition of completing an experience questionnaire and the data and answers will be used for analysis. If patients would not like to participate, standard of care radiotherapy will be delivered and this patient data will not be used for this study.
The study is expected to recruit up to 72 participants over a 2-year period using a 1:2 ratio. Up to 24 participants will be recruited to the MR Linac Arm of the study. This sample is based on resource constraints, the MR Linac can accommodate one patient per month on average. Recruitment will be a 1:2 ratio to reduce bias to the investigational arm.
To test the aim, to improve the speed of access of care, timings will be collected at certain time points throughout the pathway:
The study will consist of:
A participant is free to withdraw from the clinical trial at any point without giving a reason.
This study will run for 3 years in total, 2 years for recruitment plus one year for follow up unless early termination is required.
52 studies on the registry are indexed under Spinal Cord Compression; 19 are open to participants now.
This study's planned enrollment of 72 is above the median of 43 across 35 interventional studies indexed under Spinal Cord Compression.
Browse Spinal Cord Compression studies →The Christie NHS Foundation Trust is the lead sponsor of 100 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria MRL arm:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Using the MR Linac to deliver Radiotherapy in a single treatment without the need for a prior planning CT scan.
Radiation: Radiotherapy to the spine in a single appointment
Using a conventional linear accelerator to deliver Radiotherapy in a single treatment, participants will require a prior planning CT appointment before Radiotherapy can be delivered.
Radiation: Radiotherapy to the spine in a single appointment
8Gy/ 1# to be delivered to all participants using a single posterior direct field.
Successful treatment of Metastatic Spinal Cord Compression in a single 1 hour appointment for 80% of patients on the MRL Arm
"Successful treatment" is defined as the complete delivery of the Radiotherapy treatment beam to the area of Metastatic Spinal Cord Compression. The measurement used to assess appointment length will be time, recorded in hours, minutes and seconds. Time from the patient entering the room to the treatment beam completing.
Time frame: The event is assessed on a single day (within 24hours) over a single appointment. From the time the patient enters the treatment room to the time the radiotherapy beam is completed (Up to 2 hours in length).
80% of patients on the MRL Arm treated within 24 hours from decision to treat
The measurement used to assess will be the length of time (in days, hours, minutes). Assessed from the time the Radiotherapy referral form is submitted by the clinician to when the Radiotherapy treatment beam is completed.
Time frame: From clinician's referral to the completion of the treatment beam (Assessed for up to 7 days).
80% of patients on the MRL Arm spend less time from consent to completion of treatment when compared to the Standard of Care Arm
The measurement used to assess will be the length of time (in days, hours, minutes). Assessed from the time the Radiotherapy treatment consent form is signed by the participant to when the Radiotherapy treatment beam is completed.
Time frame: From time of treatment consent to completion of the treatment beam (Assessed for up to 7 days)
80% of the MRL Arm questionnaire scores reflect satisfaction with the treatment
The experience questionnaire collects answers on a 4-point Likert scale from 0-3. "Satisfaction" is defined as scores that are above 1 for positive questions, those that high scores indicate a positive experience. Or scores that are below 2 for negative questions, those that high scores indicate a negative experience.
Time frame: After completion of Radiotherapy (Within 2 hours of the treatment beam being completed)
The study population is representative of the population referred for Radiotherapy for Metastatic Spinal Cord Compression.
Voluntary questionnaire completed. Equality Diversity and Inclusion (EDI) data from this study will be compared to local and national EDI data statistics for MSCC patients. The percentage of characteristics represented in the study compared to the wider population.
Time frame: At the time of enrolment (within 2 hours of signing consent form)
Plan to share: No — Data for this study will be pseudo-anonymised and kept securely at The Christie, only accessible to those employed by the Christie NHS Foundation Trust. Due to the data not being fully anonymised and to preserve patient confidentiality the data from this study will not be shared.
Started Nov 2025 (actual). Primary completion is estimated for Nov 2027, 24 months after the start.
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