ACO/ARO/AIO-22 - External beam radiotherapy combined with endorectal high-dose-ratebrachytherapy in elderly and frail patients with rectal cancer.
A prospective multicentre trial of the German Rectal Cancer Study Group.
Elderly patients (age ≥70 years) with a G8-frailty score ≤ 14 based on the G8 geriatric assessment tool of frailty and/or elderly patients (age ≥70 years) with American Society of Anesthesiologists Physical Status (ASA PS) ≥ 3 and/ elderly patients (age ≥70 years) unsuitable to tolerate radical surgery as judged by the surgeon and/or elderly patients (age ≥70 years) that refuse radical surgery
Life expectancy ≥ 6 months
Male and female patients with histologically confirmed diagnosis of rectal adenocarcinoma localized 0-16 cm from the anocutaneous line as measured by rigid rectoscopy
MRI-defined cT1-3d N0/+ M0, mrCRM - / +, </= 2/3 involvement of the rectal wall circumference
Previous or current drug abuse
Other concomitant antineoplastic therapy
Prior or concurrent malignancy ≤ 3 years prior to enrolment in study (Exception: non-melanoma skin cancer or cervical carcinoma FIGO stage 0-
Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule (these conditions should be discussed with the patient before registration in the trial).
Single group
radiotherapy
Other interventionExternal beam radiotherapy and endorectal brachytherapy
Rate of Clinical Complete Response (cCR) or Near cCR at 12 Months
The primary efficacy endpoint is the proportion of patients achieving a clinical complete response (cCR) or near cCR at 12 months after the initiation of treatment, assessed through MRI and endoscopic evaluation. Quality of Life (QoL) at 12 Months Assessed using the EORTC QLQ-ELD14 questionnaire, tailored to evaluate the QoL in elderly cancer patients. The primary measure will be the change in the QoL score from baseline to 12 months.
Quality of Life and Functional Outcomes
EORTC QLQ-C30 and QLQ-CR29 for general and colorectal cancer-specific QoL. Wexner-Score for anorectal function assessment. Sustained cCR at 2 Years Proportion of patients maintaining a cCR for two years post-treatment. Disease-Free Survival (DFS) at 2 Years Time from treatment initiation to recurrence or death from any cause. Cumulative Incidence of Locoregional Regrowth Frequency of locoregional tumor regrowth in patients who initially achieved cCR. Cumulative Incidence of Distant Metastases Occurrence of distant metastases within the two-year follow-up period. Overall Survival (OS) at 2 Years Duration from treatment initiation to death from any cause. Acute and Late Toxicity Evaluation Categorized based on NCI CTCAE v.5.0, focusing on adverse events related to treatment. G8 Geriatric Assessment Evaluation of frailty and health status using the G8 assessment tool, both at baseline and during follow-ups.
Translational/Biomarker Studies
Identification of molecular biomarkers predictive of treatment response or prognosis. Follow-Up Procedures Standardized Watch and Wait (W\&W) protocol for patients achieving cCR or near cCR at six months post-treatment.
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