Clinical trial · Interventional
Magnetic Resonance Imaging (MRI)-Guided Rectal Cancer Preservation Program
MRI-guided Rectal Cancer Preservation Program
NCT07134296CI-TRIAL-00093945not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical trial is to learn if the use of MRI-guided irradiation increases the rates of rectal preservation
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MR-Guided Irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose Escalation Phase
- description
- Dose Escalation MR-guided TNT
- interventionNames
- Radiation: MR-Guided Irradiation
Primary outcomes (1)
- measure
- Total Mesorectal Excision (TME)-free survival
- timeFrame
- 5-years
- description
- To achieve 3-year TME-free survival of 75% while keeping 3-year DFS rates of 75%.
Secondary outcomes (2)
- measure
- Proctitis/Rectal Bleeding
- timeFrame
- 5-years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.