External Beam Radiotherapy Combined With Endorectal High-dose-rate Brachytherapy in Elderly and F… (NCT06729645) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
External Beam Radiotherapy Combined With Endorectal High-dose-rate Brachytherapy in Elderly and Frail Patients With Rectal Cancer
Germany80 participantsStarted 2026-09-30
Plain-language summary
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.
Who can participate
Age range70 Years
SexALL
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Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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-
1), 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).
What they're measuring
1
Rate of Clinical Complete Response (cCR) or Near cCR at 12 Months