Increasing radiotherapy doses for rectal cancer treatment
A Feasibility Study in Dose Escalated Treatment in Rectal Cancer on Mr-Linac Using Mr GuidED Adaptive Radiotherapy
This study tests if giving a higher dose of radiation can help people with advanced rectal cancer avoid surgery by seeing if it leads to better treatment results.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 13 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Royal Marsden NHS Foundation Trust Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Sutton, Surrey) |
| Trial ID | NCT06854679 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of dose-escalated radiotherapy for patients with locally advanced rectal adenocarcinoma. Participants will receive a higher dose of 60Gy compared to the standard 52.5Gy, with the aim of achieving a complete pathological response, which may allow them to avoid surgery. The study will monitor side effects and the effectiveness of this approach using MR-guided radiotherapy. Patients who respond completely will enter a surveillance program to monitor for cancer recurrence.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with locally advanced rectal adenocarcinoma who are eligible for neoadjuvant chemoradiotherapy.
Not a fit: Patients with contraindications to MRI or significant comorbidities that may lead to increased toxicity are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes for rectal cancer patients by reducing the need for surgery.
How similar studies have performed: Previous studies have indicated that increasing radiotherapy doses can improve treatment outcomes, suggesting this approach may be promising.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Sutton, Surrey
- The Royal Marsden Hospital — Sutton, Surrey, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Brian Hin, FRCR MD(res)
- Email: brian.hin@rmh.nhs.uk
- Phone: extension 4228
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.