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

MRI-guided Rectal Cancer Preservation Program

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07134296

Enrollment

Registered

2025-08-21

Start date

2025-10-01

Completion date

2030-06-30

Last updated

2025-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

Keywords

TNT, MRI-guided Irradiation, Rectal Preservation

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 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.

Interventions

RADIATIONMR-Guided Irradiation

MR-Guided Irradiation

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Total Mesorectal Excision (TME)-free survival	5-years	To achieve 3-year TME-free survival of 75% while keeping 3-year DFS rates of 75%.

Secondary

Measure	Time frame	Description
Proctitis/Rectal Bleeding	5-years	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	5-years	To achieve a Wexner Continence score of at least 90% over baseline at 2 years.

Contacts

Primary ContactBeatriz Ramos Aguirre, M.S.

ucicec@unav.es+34 948255400

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026