Rectal CancerNCT07134296
Magnetic Resonance Imaging (MRI)-Guided Rectal Cancer Preservation Program
A study testing MR-Guided Irradiation in people with Rectal Cancer, run by Clinica Universidad de Navarra, Universidad de Navarra.
Trial summary
The goal of this clinical trial is to learn if the use of MRI-guided irradiation increases the rates of rectal preservation Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- MR-Guided Irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 30 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- Patient unable to undergo an MRI examination
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
Read the 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
- To achieve 3-year TME-free survival of 75% while keeping 3-year DFS rates of 75%.
- 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.
- To achieve a Wexner Continence score of at least 90% over baseline at 2 years.
Secondary Objectives
- Determination of blood and urine biomarkers of treatment response and toxicity .
- Determination of radiomics biomarkers of treatment response and toxicity . C. Determination of rectal functionality with the Wexner Continence Score.
- Conditions
- Rectal Cancer
- Being tested
- MR-Guided Irradiation
- Keywords
- TNT, MRI-guided Irradiation, Rectal Preservation
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR-Guided IrradiationRadiation
MR-Guided Irradiation
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Phase | Experimental | Dose Escalation MR-guided TNT Receives: Radiation: MR-Guided Irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Mesorectal Excision (TME)-free survival
To achieve 3-year TME-free survival of 75% while keeping 3-year DFS rates of 75%.
Measured: 5-years
Secondary outcomes (2)
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.
Measured: 5-years
Fecal Continence
To achieve a Wexner Continence score of at least 90% over baseline at 2 years.
Measured: 5-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start1 Oct 2025 (estimated)
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rafael Martínez-Monge, M.D., Principal investigator, Clinica Universidad de Navarra, Universidad de NavarraLuis Fuertes, M.D., Principal investigator, Clinica Universidad de Navarra, Universidad de Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07134296
- Sponsor's protocol ID
- 2024.173
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2025
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: On request
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI-guided Rectal Cancer Preservation Program
- ClinicalTrials.gov ID
- NCT07134296
- Acronym / sponsor ID
- 2024.173
- Conditions
- Rectal Cancer
- Keywords
- TNT, MRI-guided Irradiation, Rectal Preservation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 21 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- To achieve 3-year TME-free survival of 75% while keeping 3-year DFS rates of 75%.
- 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.
- To achieve a Wexner Continence score of at least 90% over baseline at 2 years.
Secondary Objectives
- Determination of blood and urine biomarkers of treatment response and toxicity .
- Determination of radiomics biomarkers of treatment response and toxicity . C. Determination of rectal functionality with the Wexner Continence Score.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Phase | Experimental | Radiation: MR-Guided IrradiationDose Escalation MR-guided TNT |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (1 listed)
- Patient unable to undergo an MRI examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MR-Guided IrradiationMR-Guided Irradiation | Radiation | Dose Escalation Phase |
Primary outcome
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%.
2 secondary outcomes
Proctitis/Rectal Bleeding
Time frame: 5-years
Fecal Continence
Time frame: 5-years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Individual participant dataSharing planned: Yes. On request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rafael Martínez-Monge, M.D. principal investigator
Clinica Universidad de Navarra, Universidad de Navarra
Luis Fuertes, M.D. principal investigator
Clinica Universidad de Navarra, Universidad de Navarra
Questions about this trial
What is this clinical trial studying?
A study testing MR-Guided Irradiation in people with Rectal Cancer, run by Clinica Universidad de Navarra, Universidad de Navarra.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Beatriz Ramos Aguirre, M.S. (+34 948255400 ext. 2772, ucicec@unav.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Mesorectal Excision (TME)-free survival (time frame: 5-years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.