Magnetic Resonance Imaging (MRI)-Guided Rectal Cancer Preservation Program
MRI-guided Rectal Cancer Preservation Program
1 other identifier
interventional
32
0 countries
N/A
Brief Summary
The goal of this clinical trial is to learn if the use of MRI-guided irradiation increases the rates of rectal preservation
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2025
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2025
CompletedFirst Posted
Study publicly available on registry
August 21, 2025
CompletedStudy Start
First participant enrolled
October 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2030
August 21, 2025
August 1, 2025
4.7 years
August 12, 2025
August 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total Mesorectal Excision (TME)-free survival
To achieve 3-year TME-free survival of 75% while keeping 3-year DFS rates of 75%.
5-years
Secondary Outcomes (2)
Proctitis/Rectal Bleeding
5-years
Fecal Continence
5-years
Study Arms (1)
Dose Escalation Phase
EXPERIMENTALDose Escalation MR-guided TNT
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patient unable to undergo an MRI examination
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rafael Martínez-Monge, M.D.
Clínica Universidad de Navarra
- PRINCIPAL INVESTIGATOR
Luis Fuertes, M.D.
Clínica Universidad de Navarra
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2025
First Posted
August 21, 2025
Study Start
October 1, 2025
Primary Completion (Estimated)
June 30, 2030
Study Completion (Estimated)
June 30, 2030
Last Updated
August 21, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- 5-years
- Access Criteria
- On request
On request