Magnetic Resonance Tumour Regression Grade as Biomarker for Stratified Management of Rectal Cancer Patients

• Status: Recruiting
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial evaluates a novel imaging method called magnetic resonance tumour regression grade (mrTRG) to assess how well a tumour has responded to chemoradiotherapy in patients with rectal cancer. The TRIGGER Trial aims to evaluate mrTRG as a tool for stratifying the management of patients according to their response to treatment.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Royal Marsden NHS Foundation Trust
• Treatments: Capecitabine; Fluorouracil; Folic Acid; Leucovorin; Levoleucovorin; Oxaliplatin

Criteria

Inclusion Criteria:

1. Have a biopsy-confirmed adenocarcinoma 0-15cm from the anal verge (on MRI or rigid sigmoidoscopy).

2. Have locally Advanced Rectal Carcinoma diagnosed by MRI (mrCRM unsafe or ≥mrT3c [>5mm beyond muscularis propria] or mrEMVI positive disease)

3. Be deemed to require chemoradiotherapy.

4. Scheduled to receive 45Gy - 55Gy long course radiotherapy.

5. Have provided written informed consent to participate in the study.

6. Be aged 18 years or over.

Exclusion Criteria:

1. Have metastatic disease (including resectable liver metastases).

2. Are contraindicated for MRI e.g. non-MR compatible hip prosthesis, cardiac pacemaker.

3. Are scheduled to receive less than 45Gy or more than 55Gy long course radiotherapy.

4. Are contraindicated for chemoradiotherapy (CRT)

5. Hypersensitivity or contraindication to the drug(s) associated with the planned choice of systemic chemotherapy (CAPOX, FOLFOX or single agent 5-FU or capecitabine) as stated in the SmPC for each of the drugs.

6. Are receiving or planned to receive treatment outside of that stipulated by the protocol, such as an alternative cytotoxic or investigational drug.

7. Are pregnant, breastfeeding or unable / unwilling to comply with pregnancy prevention guidelines.

8. Any other malignant disease within the preceding 5 years with the exception of non- melanomatous skin cancer, carcinoma in situ and early stage disease with <5% recurrence risk.