External Beam Radiotherapy Combined With Endorectal High-dose-rate Brachytherapy in Elderly and Frail Patients With Rectal Cancer

Starting soon · Not applicable

Conditions studied: Rectal Cancer

In brief

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.

Key facts

Study ID

NCT06729645

Run by

University Hospital of Cologne

People needed

80

Starts

2026-09-30

Expected to finish

2031-12-30

Last updated by the study team

2026-05-01

Who can join

Age: 70 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Staging requirements: High-resolution, thin-sliced (i.e. 3mm) magnetic resonance imaging (MRI) of the pelvis is the mandatory local staging procedure.
• Spiral-CT of the abdomen and chest to exclude distant metastases.

You may not qualify if…

• 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-
• , unless the patient is continuously disease-free
• 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).

Where it is running

• Klinikverbund Allgäu — Kempten, BaBaden-Württembergs, Germany
• Frankfurt Universitätsklinikum — Frankfurt am Main, Hesse, Germany
• Klinik für Strahlentherapie, Cyberknife und Radioonkologie Universität zu Köln — Cologne, North Rhine-Westphalia, Germany
• Leipzig, Universitätsklinikum — Leipzig, Saxony, Germany

Full record on ClinicalTrials.gov

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