NCT05916040 Total Neoadjuvant Treatment of Rectal Cancer by MRI-guided Radiotherapy
| NCT ID | NCT05916040 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitair Ziekenhuis Brussel |
| Condition | Rectal Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 35 participants |
| Start Date | 2024-11-28 |
| Primary Completion | 2025-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 35 participants in total. It began in 2024-11-28 with a primary completion date of 2025-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Mark De Ridder, MD
PRINCIPAL INVESTIGATOR
Department of Radiotherapy, UZ Brussel, Vrije Universiteit Brussel
Frequently Asked Questions
Who can join the NCT05916040 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Rectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05916040 currently recruiting?
Yes, NCT05916040 is actively recruiting participants. Contact the research team at mark.deridder@uzbrussel.be for enrollment information.
Where is the NCT05916040 trial being conducted?
This trial is being conducted at Jette, Belgium.
Who is sponsoring the NCT05916040 clinical trial?
NCT05916040 is sponsored by Universitair Ziekenhuis Brussel. The principal investigator is Mark De Ridder, MD at Department of Radiotherapy, UZ Brussel, Vrije Universiteit Brussel. The trial plans to enroll 35 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.