TY - JOUR
T1 - ACO/ARO/AIO-22 – External beam radiotherapy combined with endorectal high-dose-rate brachytherapy in elderly and frail patients with rectal cancer
T2 - A prospective multicentre trial of the German Rectal Cancer Study Group
AU - Dapper, Hendrik
AU - Fleischmann, Maximilian
AU - Tselis, Nikolaos
AU - Diefenhardt, Markus
AU - Hofheinz, Ralf Dieter
AU - Weiß, Christian
AU - Grabenbauer, Gerhard G.
AU - Merten, Ricarda
AU - Grosu, Anca Ligia
AU - Kirste, Simon
AU - Rieken, Stefan
AU - Claßen, Johannes
AU - Langer, Christian
AU - Kuhnt, Thomas
AU - Schmidberger, Heinz
AU - Ghadimi, Michael
AU - Giordano, Frank
AU - Nestle, Ursula
AU - Koerber, Stefan A.
AU - Bock, Felix
AU - Geiger, Matthias
AU - Polat, Bülent
AU - Bruns, Christiane J.
AU - Dieplinger, Georg
AU - Popp, Felix
AU - Zander, Thomas
AU - Brunner, Thomas
AU - Tribius, Silke
AU - Arnold, Dirk
AU - Wurschi, Georg
AU - Piso, Pompiliu
AU - Friede, Tim
AU - Hörner-Rieber, Juliane
AU - Gkika, Eleni
AU - Rödel, Claus
AU - Fokas, Emmanouil
N1 - Publisher Copyright:
© 2025 The Author(s)
PY - 2025/7
Y1 - 2025/7
N2 - Purpose: Rectal cancer disproportionately affects the elderly population, with more than half of cases diagnosed in individuals aged 70 years or older. Frail patients in this group often face significant challenges tolerating the standard treatment of total mesorectal excision (TME), due to elevated risks of surgical complications and perioperative morbidity. Advances in radiotherapy techniques offer a viable alternative, providing effective tumor control while minimizing treatment-related toxicity. Recent clinical trials, including OPERA and MORPEUS, have demonstrated that dose-escalated radiotherapy, which integrates external beam (chemo)radiotherapy (EBRT) with high-dose-rate endorectal brachytherapy (HDR-BT) or contact X-ray brachytherapy (CXB), can achieve high clinical response rates and facilitate organ preservation in younger, healthier patient cohorts. Building on these findings, the ACO/ARO/AIO-22 study seeks to adapt these innovative approaches to meet the needs of elderly and frail patients with rectal cancer. Methods/Design: The ACO/ARO/AIO-22 trial is a prospective multicentre controlled trial. Elderly (age ≥70 years) and/or frail patients with non-metastatic rectal adenocarcinoma (cT1-3d N0/+ M0, mrCRM − / +) localized 0–16 cm from the ano-cutaneous line, unable to undergo radical surgery can be included. The initial treatment comprises an external beam radiation (EBRT) regime with 13 × 3 Gy (total: 39 Gy) over a period of two and a half weeks. Following initial restaging 6.5 weeks after completion of EBRT, endorectal HDR-BT will be delivered with 3 weekly fractions of 8 Gy to a total dose of 24 Gy (prescribed at the radial margin of the tumor; with a maximum prescription depth of 10 mm); alternatively, with CXB with 90 Gy in 3 weekly fractions. The primary objective is complete or near complete clinical response (cCR or ncCR) and the second primary endpoint is quality of life (QoL) measured with the EORTC QLQ-ELD14, both at 12 months after treatment start. Discussion: The ACO/ARO/AIO-22 prospective multicentre trial will evaluate organ preservation rates and QoL after combining EBRT with endorectal HDR-BT in elderly and/or frail patients with rectal cancer. Trial Registration: Clinicialtrials.gov number: NCT06729645.
AB - Purpose: Rectal cancer disproportionately affects the elderly population, with more than half of cases diagnosed in individuals aged 70 years or older. Frail patients in this group often face significant challenges tolerating the standard treatment of total mesorectal excision (TME), due to elevated risks of surgical complications and perioperative morbidity. Advances in radiotherapy techniques offer a viable alternative, providing effective tumor control while minimizing treatment-related toxicity. Recent clinical trials, including OPERA and MORPEUS, have demonstrated that dose-escalated radiotherapy, which integrates external beam (chemo)radiotherapy (EBRT) with high-dose-rate endorectal brachytherapy (HDR-BT) or contact X-ray brachytherapy (CXB), can achieve high clinical response rates and facilitate organ preservation in younger, healthier patient cohorts. Building on these findings, the ACO/ARO/AIO-22 study seeks to adapt these innovative approaches to meet the needs of elderly and frail patients with rectal cancer. Methods/Design: The ACO/ARO/AIO-22 trial is a prospective multicentre controlled trial. Elderly (age ≥70 years) and/or frail patients with non-metastatic rectal adenocarcinoma (cT1-3d N0/+ M0, mrCRM − / +) localized 0–16 cm from the ano-cutaneous line, unable to undergo radical surgery can be included. The initial treatment comprises an external beam radiation (EBRT) regime with 13 × 3 Gy (total: 39 Gy) over a period of two and a half weeks. Following initial restaging 6.5 weeks after completion of EBRT, endorectal HDR-BT will be delivered with 3 weekly fractions of 8 Gy to a total dose of 24 Gy (prescribed at the radial margin of the tumor; with a maximum prescription depth of 10 mm); alternatively, with CXB with 90 Gy in 3 weekly fractions. The primary objective is complete or near complete clinical response (cCR or ncCR) and the second primary endpoint is quality of life (QoL) measured with the EORTC QLQ-ELD14, both at 12 months after treatment start. Discussion: The ACO/ARO/AIO-22 prospective multicentre trial will evaluate organ preservation rates and QoL after combining EBRT with endorectal HDR-BT in elderly and/or frail patients with rectal cancer. Trial Registration: Clinicialtrials.gov number: NCT06729645.
UR - https://www.scopus.com/pages/publications/105002663835
UR - https://www.scopus.com/pages/publications/105002663835#tab=citedBy
U2 - 10.1016/j.ctro.2025.100958
DO - 10.1016/j.ctro.2025.100958
M3 - Article
C2 - 40276115
AN - SCOPUS:105002663835
SN - 2405-6308
VL - 53
JO - Clinical and Translational Radiation Oncology
JF - Clinical and Translational Radiation Oncology
M1 - 100958
ER -