Magnetic Resonance Tumour Regression Grade (mrTRG) as a Novel Biomarker - Phase III Non CTIMP Trial

Launched by IMPERIAL COLLEGE LONDON · Mar 4, 2016

Keywords

ClinConnect Summary

The TRIGGER clinical trial is studying a new way to help manage locally advanced rectal cancer. It offers an option called "watch and wait" for patients who show a good response to treatment, which means they might avoid surgery. The trial involves patients who are getting pre-operative treatment and will have regular MRI scans to monitor their progress. Based on these scans, a specially trained radiologist will assess how well the treatment is working using a grading system called mrTRG. If patients have a good response (grades 1 or 2), they may be able to skip surgery, while those with a poorer response (grades 3 to 5) will receive further treatment plans from a team of specialists.

To join the trial, patients must have a specific type of locally advanced rectal cancer that has been confirmed by a biopsy. They should also need preoperative chemotherapy or radiation therapy. Patients of any age between 58 and 43 are eligible, and both men and women can participate. Throughout the trial, participants will fill out quality of life questionnaires at different times to help researchers understand how the treatment affects them. Overall, this trial is a unique opportunity to explore new management strategies for rectal cancer while ensuring patients receive the best possible care.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. MRI defined locally advanced rectal carcinoma i.e. one or more: greater than or equal to mrT3c; mrEMVI positive; mr N1c; mr CRM positive
• • 2. Biopsy confirmed adenocarcinoma of radiologically defined rectum
• • 3. Be deemed to require preoperative chemoradiotherapy (CRT) or total neoadjuvant therapy (TNT)
• Exclusion Criteria:
• • 1. Metastatic disease
• • 2. MRI, radiotherapy and/or chemotherapy contraindications
• • 3. A post-treatment MRI performed more than 10 weeks after the completion of radiotherapy if given
• • 4. Previous malignancy within preceding 5 years if risk of recurrence \>5%