Clinical trial · Observational
Total Neoadjuvant Treatment of Rectal Cancer by MRI-guided Radiotherapy
Total Neoadjuvant Treatment of Rectal Cancer by MRI-guided Radiotherapy: a Prospective Observational Study
- 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 TNTRect trial is a prospective observational study that will evaluate the outcome of MR-guided stereotactic body radiotherapy (SBRT) with a simultaneous integrated boost in a hypofractionated treatment of rectum cancer. Patients will be treated in 5 daily fractions of 5 Gy within an overall treatment time (OTT) of 5 days. A simultaneous integrated boost (SIB) till 30Gy will be delivered to the gross tumor volume. Patients will be treated with daily adaptive radiotherapy and online tumor gating on the MRIdian system (ViewRay Inc.). The aim of the study is to improve the complete clinical response rate to offer more patients an organ preserving approach. The primary endpoint is patient response to the treatment, assessed by endoscopy and MRI, or by medical pathology reports after potential resection was performed. As secondary endpoints local control, disease-free survival, overall survival and the patient's quality of life \& hospital anxiety and depression will be measured.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Questionnaires before, during and after radiotherapy | Other | — | UNRESOLVED |
| Radiotherapy with MRIdian with simultaneous integrated boost | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- TNTRect MRI-guided radiotherapy group with simultaneous integrated boost
- description
- Interventions include having received MRI-guided therapy with simultaneous integrated boost on the gross tumor volume in patients with rectum cancer.
- interventionNames
- Device: Radiotherapy with MRIdian with simultaneous integrated boost
- Other: Questionnaires before, during and after radiotherapy
Primary outcomes (1)
- measure
- Response to therapy
- timeFrame
- up to 25 weeks after start of radiotherapy
- description
- After radiotherapy and chemotherapy are administered, the patient will be evaluated for a potential watchful-waiting approach where, together with the patient, can be opted too not perform a TME (total mesorectal excision). This outcome measure registers if the therapy works.
Secondary outcomes (4)
- measure
- Quality of life assessment via QLQ-C30
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Locally advanced rectal cancer Exclusion Criteria: * Patients with unresectable metastatic disease at diagnosis * Patients with an ECOG performance status \> 2 * Patients not deemed fit for radiotherapy, chemotherapy or surgery
References
Publications (0)
Data not yet available