Clinical trial · Observational
Chemo-radiotherapy as Main Treatment Strategy for Rectal Cancer. Can we Provide a More Precise and Effective Treatment
- 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 purpose of this project is to obtain important information about the tumour and surrounding organs during preoperative chemo-radiotherapy for patients with adenocarcinoma of the rectum. The knowledge generated in this project has the potential to make future radiotherapy treatments (RT) of rectal cancer patients more precise, with less side effects. This could lead the way to make chemo-radiotherapy the main treatment modality and spare a large group of patients from the risk of severe complications after surgery. Specifically, we aim to obtain: * A characterization of systematic and random changes in position and shape of tumours and surrounding organs during RT. * A patient-specific pre-treatment characterization of random uncertainties in position and shape of the tumour during radiotherapy. This will be used to create and assess an individual, patient-specific treatment strategy, with the possibility to implement an adaptive RT strategy using the information obtained from the MRI-scans during treatment. * Information about treatment response and local toxicity from morphological and functional data before, during and after CRT.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Malignant Neoplasm | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Rectal Adenocarcinoma | Rectal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Changes in position and shape of the tumour during RT.
- timeFrame
- Baseline, 3-4 days, an average of 9 days, an average of 16 days, an average of 22 days, average of 37 days
- description
- Use additional MRI scans before radiotherapy (for random changes) and during radiotherapy (for systematic changes). The gross tumor volume (GTV), clinical target volume (CTV) will be delineated separately on CT and all MRI-scans. Using a rigid bony anatomy-based method, the MRI-scans will be registered to the planning CT scan, to allow a comparison of the position and shape variations of the volumes. The information gained will be used to evaluate the relevance of current population based planning target volume (PTV) margins, and, if relevant, provide updated recommendations for treatment margins.
Secondary outcomes (5)
- measure
- Changes in position and shape of organs during RT.
- timeFrame
- Baseline, 3-4 days, an average of 9 days, an average of 16 days, an average of 22 days, average of 37 days
- description
- Use additional MRI scans before radiotherapy (for random changes) and during radiotherapy (for systematic changes). The organs at risk (OAR) will be delineated separately on CT and all MRI-scans. Using a rigid bony anatomy-based method, the MRI-scans will be registered to the planning CT scan, to allow a comparison of the position and shape variations of the volumes.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: All patients referred to standard chemoradiotherapy for locally advanced rectal cancer. Exclusion Criteria: * Prior surgery in pelvic minor region * Pacemaker * Neurostimulator * Other non MR-compatible implants * Pregnancy * Incapable of undergoing MRI * Incapable of understanding the patient information * Allergic to contrast agent * Contraindication for Buscopan * Reduced renal function (GFR \< 50 ml/min) Patients who cannot tolerate the contrast used for DCE-MRI (due to allergies, contraindications for Buscopan or reduced renal function (GFR \< 50 ml/min)) will still be offered inclusion in the study, but without the contrast-based MRI scans.
References
Publications (0)
Data not yet available