Dose Escalated Radiotherapy for Rectal Cancers Using MR-guided Radiotherapy

Launched by ROYAL MARSDEN NHS FOUNDATION TRUST · Feb 25, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to treat rectal cancer using higher doses of radiotherapy while adapting the treatment based on how the cancer responds during therapy. The goal is to see if increasing the dose from the standard 52.5Gy to 60Gy can lead to a higher chance of completely eradicating the cancer, which could allow some patients to avoid surgery. The treatments will be delivered using a special machine called an MR-linac, which combines imaging and radiotherapy, allowing doctors to target the cancer more precisely while minimizing exposure to healthy tissues.

To participate in this trial, you need to be at least 18 years old and have a confirmed diagnosis of locally advanced rectal adenocarcinoma that requires treatment. You should also be able to receive chemotherapy at the same time. If you join, you can expect to receive daily treatments for about five weeks, along with regular monitoring through tests like MRI scans. While there may be a risk of some side effects, the adaptive approach aims to keep these to a minimum. Ultimately, the researchers hope this study will help improve long-term outcomes for rectal cancer patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.