About this trial
The goal of this clinical trial is to learn if the use of MRI-guided irradiation increases the rates of rectal preservation
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 18 or older with primary Stage II (T3-4, N0) or Stage III (any T, N1-2) biopsy-proven rectal cancer
No prior radiation therapy to the target areas;
Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3
Platelets ≥ 50,000 cells/mm3.
Disqualifiers
Patient unable to undergo an MRI examination
Trial design
Single group
Treatments tested in this trial
MR-Guided Irradiation
RadiationMR-Guided Irradiation
Treatment groups
Trial outcomes
Primary outcomes
Total Mesorectal Excision (TME)-free survival
To achieve 3-year TME-free survival of 75% while keeping 3-year DFS rates of 75%.
Secondary outcomes
Proctitis/Rectal Bleeding
To achieve a CTCAE v5 grade 2-3 proctitis of less than 10% and grade 2-3 rectal bleeding rate of \<2% at 2 years.
Fecal Continence
To achieve a Wexner Continence score of at least 90% over baseline at 2 years.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: