Status:
NOT_YET_RECRUITING
Magnetic Resonance Imaging (MRI)-Guided Rectal Cancer Preservation Program
Lead Sponsor:
Clinica Universidad de Navarra, Universidad de Navarra
Conditions:
Rectal Cancer
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to learn if the use of MRI-guided irradiation increases the rates of rectal preservation
Detailed Description
HYPOTHESIS The implementation of Magnetic Resonance Image Guided Radiotherapy (MRgRT) into a TNT Program renders improved TME-free rates due to the better visualization and online dose-adaptation of ...
Eligibility Criteria
Inclusion
- 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;
- ECOG 0-2 with medical status not contraindicating treatment with radical intent including TNT and TME (if required) and with basal laboratory values as follows:
- Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3
- Platelets ≥ 50,000 cells/mm3.
- Hemoglobin ≥ 8.0 g/dl.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 4 x upper limit of normal.
- Total bilirubin \< 2 x upper normal mg/dL.
- Alkaline phosphatase \< 4 x upper limit of normal.
Exclusion
- Patient unable to undergo an MRI examination
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2030
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT07134296
Start Date
October 1 2025
End Date
June 30 2030
Last Update
August 21 2025
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