Magnetic Resonance Imaging (MRI)-Guided Rectal Cancer Preservation Program

MRI-guided Rectal Cancer Preservation Program

The goal of this clinical trial is to learn if the use of MRI-guided irradiation increases the rates of rectal preservation

Study Overview

• Status: Not yet recruiting
• Conditions: Rectal Cancer
• Intervention / Treatment: Radiation: MR-Guided Irradiation

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 the Gross Tumor Volume (GTV).

Rationale In the radiation setting, MRI provides superior soft tissue contrast compared to standard onboard X-ray imaging improving inter- and intra- observer delineation variation. MRgRT offers the opportunity to adapt the plan at each fraction to the anatomical changes seen. This is especially important in rectal cancer where the rectum is subject to interfractional position changes, volume shrinkage and intrafractional shape and size variation due to the variability in rectal filling.

Primary Objectives

A. To achieve 3-year TME-free survival of 75% while keeping 3-year DFS rates of 75%.

B. 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.

C. To achieve a Wexner Continence score of at least 90% over baseline at 2 years.

Secondary Objectives

A. Determination of blood and urine biomarkers of treatment response and toxicity .

B. Determination of radiomics biomarkers of treatment response and toxicity . C. Determination of rectal functionality with the Wexner Continence Score.

• Study Type: Interventional
• Enrollment (Estimated): 32
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Beatriz Ramos Aguirre, M.S.; Phone Number: 2772 +34 948255400; Email: ucicec@unav.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• Patient unable to undergo an MRI examination

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose Escalation Phase; Dose Escalation MR-guided TNT	Radiation: MR-Guided Irradiation; MR-Guided Irradiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5-years
Fecal Continence	To achieve a Wexner Continence score of at least 90% over baseline at 2 years.	5-years

Collaborators and Investigators

• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra
• Investigators: Principal Investigator: Rafael Martínez-Monge, M.D., Clinica Universidad de Navarra; Principal Investigator: Luis Fuertes, M.D., Clinica Universidad de Navarra

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2025
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): June 30, 2030

Study Registration Dates

• First Submitted: August 12, 2025
• First Submitted That Met QC Criteria: August 20, 2025
• First Posted (Actual): August 21, 2025

Study Record Updates

• Last Update Posted (Actual): August 21, 2025
• Last Update Submitted That Met QC Criteria: August 20, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: TNT; MRI-guided Irradiation; Rectal Preservation
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Rectal Neoplasms
• Other Study ID Numbers: 2024.173

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: On request
• IPD Sharing Time Frame: 5-years
• IPD Sharing Access Criteria: On request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No