Actively Recruiting
Dose Escalated Treatment in Rectal Cancer Using MR-Linac and Adaptive Radiotherapy
Led by Royal Marsden NHS Foundation Trust · Updated on 2025-03-03
13
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new approach to treat locally advanced rectal adenocarcinoma by increasing the dose of radiotherapy while using adaptive techniques to target the cancer more precisely. The study aims to see if this dose escalation can improve the chance of completely treating the cancer, known as complete pathological response, potentially allowing patients to avoid surgery and its long-term complications. The trial uses a novel MR-linac machine that combines MRI imaging with radiotherapy to adapt treatment daily based on tumor changes. Participants will receive a standard dose of 45Gy to the mesorectum and elective nodal areas, and 52.5Gy to the primary tumor area over 25 treatment sessions. From the second week of treatment, those with visible tumor may receive a boost dose up to 60Gy. The MR-linac allows for daily adjustments to the radiation plan, focusing treatment on the tumor while sparing healthy tissue. Non-adaptive treatments can be delivered using either the MR-linac or a CT-linac system. During the study, patients will undergo regular assessments including MRI scans, camera tests (sigmoidoscopy), and patient-reported questionnaires to monitor side effects and tumor response. Researchers will track treatment completion rates on the MR-linac, gastrointestinal and genitourinary side effects, tumor recurrence, and pathological response over up to two years. The study's total participation includes the treatment period and long-term follow-up to evaluate safety and effectiveness of this adaptive, higher-dose radiotherapy approach.
CONDITIONS
Brief Title
Dose Escalated Radiotherapy for Rectal Cancers Using MR-guided Radiotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histological confirmation of locally advanced rectal adenocarcinoma requiring neoadjuvant chemoradiotherapy
- Suitable for concomitant chemotherapy
- Disease included within treatment field size of MR-Linac
- WHO Performance status 0-2
- Ability and willingness to provide informed consent
- Willingness to comply with patient reported outcome questionnaires during the study
You will not qualify if you...
- Contraindications to MRI such as pacemaker, mobile metal implants, or claustrophobia
- Disease outside maximum radiotherapy treatment field length
- Comorbidities increasing risk of significant toxicity, e.g. inflammatory bowel disease
- Unilateral or bilateral total hip replacement or other pelvic metalwork causing imaging artefacts
- Previous pelvic radiotherapy
- Need for induction chemotherapy prior to chemoradiotherapy
- Previous invasive malignancy within 2 years except certain skin cancers, low risk bladder cancer, or small renal masses on surveillance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 5 weeks
Participants receive dose escalated radiotherapy for rectal cancer with standard and boosted doses delivered over multiple weeks depending on visible disease.
Daily visits for radiotherapy sessions over 25 fractions
Duration - Up to 24 months post-treatment
Participants are monitored for toxicity, pathological response, recurrence, and patient-reported outcomes up to 24 months after completing treatment.
Visits at 6 and 12 weeks, and at 1 and 2 years post-treatment
Trial Site Locations
Total: 1 location
1
The Royal Marsden Hospital
Sutton, Surrey, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
B
Brian Hin, FRCR MD(res)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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