the Efficacy of MR-guided Online Adaptive Radiotherapy for Locally Advanced Rectal Cancer

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

Based on preliminary findings on the motion error of the clinical target volume (CTV) in MR-guided adaptive radiotherapy (MRgART) for locally advanced rectal cancer (LARC), this study aims to reduce CTV-to-PTV margins and evaluate the complete response (CR) rate following MRgART in LARC patients. Additionally, it will investigate the safety and tolerability of MRgART, as well as its impact on:

3-year organ preservation rate

Local recurrence rate in patients under a "watch-and-wait" approach

3-year overall survival (OS), disease-free survival (DFS), and local progression-free survival (LPFS).

Furthermore, by analyzing ADC maps of the gross tumor volume (GTV), this study will characterize treatment responses and spatial deformation in metabolically active tumor subregions. These insights may inform future dose-escalation strategies for LARC radiotherapy, with the ultimate goal of improving prognosis and quality of life in this patient population.

Eligibility criteria

Qualifiers

Age 18-75 years, regardless of gender;

Staged as II/III (cT3-T4N0 or cT2-4N+, no distant metastasis) by MRI or endoscopic ultrasound (according to the AJCC Cancer Staging Manual, 8th Edition);

Fibrocolonoscopy or digital rectal examination confirms the lower border of the lesion is ≤10 cm from the anal verge;

Pathologically confirmed or reviewed diagnosis of rectal adenocarcinoma;

Disqualifiers

Presence of MRI-incompatible metal implants or claustrophobia;

Previous treatment with anti-PD-1/L1, anti-CTLA-4 immunotherapy, or other experimental immunotherapeutic drugs;

History of severe autoimmune diseases, including active inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (e.g., Wegener's granulomatosis), etc.;

Symptomatic interstitial lung disease or active infectious/non-infectious pneumonia;

Trial design

Treatments tested in this trial

  • short course radiotherapy using MR-linac

Treatment groups

49 Participants
are divided into 1 treatment group

Locations

This trial has no locations