Magnetic Resonance Imaging (MRI)-Guided Rectal Cancer Preservation Program
MRI-guided Rectal Cancer Preservation Program
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
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
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Dose Escalation Phase
Dose Escalation MR-guided TNT
|
MR-Guided Irradiation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Mesorectal Excision (TME)-free survival
Time Frame: 5-years
|
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
Time Frame: 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.
|
5-years
|
|
Fecal Continence
Time Frame: 5-years
|
To achieve a Wexner Continence score of at least 90% over baseline at 2 years.
|
5-years
|
Collaborators and Investigators
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)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024.173
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
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
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.