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

NCT07080411 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2025-07-23

No results posted yet for this study

Summary

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.

Conditions

Interventions

RADIATION

short course radiotherapy using MR-linac

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.

Sponsors & Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2026-12-31
Completion
2029-12-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07080411 on ClinicalTrials.gov