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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
49
Patients in the MRgART group will receive standard total neoadjuvant therapy (TNT) and surgical treatment, including short-course radiotherapy and chemotherapy, with the addition of immunotherapy at the investigator's discretion based on individual patient characteristics.
complete response (CR)
Absence of residual cancer cells on the final analysis of the tumor and lymph node
Time frame: 8 weeks post chemoradiotherapy
adverse events (AE)
Toxicity including anorexia, nausea, vomiting, diarrhoea, dermatitis, proctitis, urinary frequency/urgency according to CTCAE criteria v5.0
Time frame: 2 years after radiotherapy
organ preservation rate
Sphincter Preservation rates 8 weeks post chemoradiotherapy at surgery.Percentage of patients who underwent sphincter salvage surgery after chemoradiotherapy
Time frame: 8 weeks after chemoradiotherapy
local recurrence rate (LCR)
Time frame: From the completion of total neoadjuvant therapy (TNT) or post-surgery until 3 years post-treatment follow-up
disease-free survival (DFS)
Time from study entry to disease recurrence or death
Time frame: From the completion of total neoadjuvant therapy (TNT) or post-surgery until 3 years post-treatment follow-up
overall survival (OS)
Time from study entry to death
Time frame: From enrollment until 3 years post-treatment follow-up
local progression-free survival (LPFS)
Time from study entry to local recurrence
Time frame: From the completion of total neoadjuvant therapy (TNT) or post-surgery until 3 years post-treatment follow-up
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