Increasing radiotherapy doses for rectal cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Short-course radiotherapy plus intensified chemotherapy and targeted therapy with immunotherapy for high-risk rectal cancer

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• Rectal brachytherapy boost to try to avoid surgery for low-lying residual rectal cancer after total neoadjuvant therapy

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.