Total Neoadjuvant Treatment of Rectal Cancer by MRI-guided Radiotherapy

Trial Title: Total Neoadjuvant Treatment of Rectal Cancer by MRI-guided Radiotherapy

NCT ID: NCT05916040

Condition: Rectal Cancer

Conditions: Official terms:
Rectal Neoplasms

Conditions: Keywords:
Radiation therapy
MR-guided radiotherapy
Stereotactic body radiotherapy
Total Neo-adjuvant Treatment

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Device
Intervention name: Radiotherapy with MRIdian with simultaneous integrated boost
Description: radiotherapy during 5 days given in 5 weekdays with simultaneous integrated boost
Arm group label: TNTRect MRI-guided radiotherapy group with simultaneous integrated boost

Other name: Radiotherapy with MRIdian (ViewRay Inc.)

Intervention type: Other
Intervention name: Questionnaires before, during and after radiotherapy
Description: Questionnaires consisting of 3 quality of life scales and 1 mental state scale: - EORTC QLQ-C30 - EORTC QLQ-CR29 - Low Anterior Resection Syndrome Score (LARS) questionnaire - Hospital Anxiety and Depression Scale (HADS) questionnaire
Arm group label: TNTRect MRI-guided radiotherapy group with simultaneous integrated boost

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.

Criteria for eligibility:

Study pop:
Patients diagnosed with rectal cancer aged 18 years or older.

Sampling method: Non-Probability Sample
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: UZ Brussel - Dienst Radiotherapie

Address:
City: Jette
Zip: 1090
Country: Belgium

Status: Recruiting

Contact:
Last name: Mark De Ridder, PhD, MD
Email: mark.deridder@uzbrussel.be

Start date: September 1, 2024

Completion date: June 30, 2030

Lead sponsor:
Agency: Universitair Ziekenhuis Brussel
Agency class: Other

Source: Universitair Ziekenhuis Brussel

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05916040