To Determine Whether it is Feasible to Treat Patients Requiring Urgent Radiotherapy Diagnosed With Metastatic Cord Compression (MSCC) on the Magnetic Resonance Linear Accelerator (MRL) in a Single Appointment and Compare it to the Standard of Care Radiotherapy Pathway

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Christie NHS Foundation Trust

About this trial

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:

* Can the MRL deliver successful treatment of MSCC in a single 1-hour appointment? * Can the MRL treat participants within 24 hours from the doctor's decision to treat? * Did it take less time from consent to completion of treatment when patients were treated on the MRL? * Do the questionnaire scores reflect satisfaction with treatment on the MRL? Researchers will compare treatment on the MRL in one appointment to a group receiving standard of care radiotherapy in two appointments.

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Confirmed Diagnosis of MSCC

Referred for an 8Gy, Single Fraction of Radiotherapy

18 years or older.

Able to give informed consent in writing or verbally.

Disqualifiers

Participant does not have capacity and cannot give informed consent.

Any evidence of significant clinical disorder or laboratory finding which, in the opinion of the investigator, make it undesirable for the patient to participate in the study.

Participant is unwilling to allow researchers to access their clinical notes and diagnostic scans.

Participant is unwilling to complete an experience questionnaire

Trial design

Design model

Parallel

Treatments tested in this trial

  • Radiotherapy to the spine in a single appointment

    Radiation

    8Gy/ 1# to be delivered to all participants using a single posterior direct field.

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: MRLActive comparator 1 intervention
Group B: Standard of CarePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Secondary outcomes

1

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).
2

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)
3

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)
4

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)

Other outcomes

Sponsors and contacts

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