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

NCT06729645 | Not Yet Recruiting DMC

• 2 other identifiers: ACO/ARO/AIO-2270115482
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  12 Months

Secondary Outcomes (1)

• Quality of Life and Functional Outcomes

  2 years

Other Outcomes (1)

• Translational/Biomarker Studies

  6 months

Study Arms (1)

Patients with Rectal cancer

EXPERIMENTAL

Patients will be initially treated with EBRT with 13 x 3 Gy to a total dose of 39 Gy to the primary tumor and pelvic lymph node, over a period of 2.5 weeks. Restaging with pelvic MRI and endoscopy will then be performed 6.5 weeks after completion of EBRT and prior to the first endorectal HDR-BT fraction to evaluate initial therapy response and the residual extent of the disease for target outlining. Following that, endorectal HDR-BT will be delivered with 3 x 8 Gy to a total dose of 24 Gy (dose prescription: 5 mm depth for cT1 tumors; 10 mm depth for cT2-3 tumors), with each endorectal brachytherapy application performed once weekly.

Other: radiotherapy

Interventions

radiotherapy OTHER

External beam radiotherapy and endorectal brachytherapy

Patients with Rectal cancer

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

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).

Sponsors & Collaborators

• University Hospital of Cologne: lead

Study Sites (4)

Klinikverbund Allgäu

Kempten, BaBaden-Württembergs, 87439, Germany

Location

Frankfurt Universitätsklinikum

Frankfurt am Main, Hesse, 60590, Germany

Location

Klinik für Strahlentherapie, Cyberknife und Radioonkologie Universität zu Köln

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Leipzig, Universitätsklinikum

Leipzig, Saxony, 04103, Germany

Location

Related Publications (2)

• Fleischmann M, Diefenhardt M, Nicolas AM, Rodel F, Ghadimi M, Hofheinz RD, Greten FR, Rodel C, Fokas E; German Rectal Cancer Study Group. ACO/ARO/AIO-21 - Capecitabine-based chemoradiotherapy in combination with the IL-1 receptor antagonist anakinra for rectal cancer Patients: A phase I trial of the German rectal cancer study group. Clin Transl Radiat Oncol. 2022 Apr 6;34:99-106. doi: 10.1016/j.ctro.2022.04.003. eCollection 2022 May.

  PMID: 35449546 BACKGROUND

• Dapper H, Fleischmann M, Tselis N, Diefenhardt M, Hofheinz RD, Weiss C, Grabenbauer GG, Merten R, Grosu AL, Kirste S, Rieken S, Classen J, Langer C, Kuhnt T, Schmidberger H, Ghadimi M, Giordano F, Nestle U, Koerber SA, Bock F, Geiger M, Polat B, Bruns CJ, Dieplinger G, Popp F, Zander T, Brunner T, Tribius S, Arnold D, Wurschi G, Piso P, Friede T, Horner-Rieber J, Gkika E, Rodel C, Fokas E; German Rectal Cancer Study Group. ACO/ARO/AIO-22 - External beam radiotherapy combined with endorectal high-dose-rate brachytherapy in elderly and frail patients with rectal cancer: A prospective multicentre trial of the German Rectal Cancer Study Group. Clin Transl Radiat Oncol. 2025 Apr 13;53:100958. doi: 10.1016/j.ctro.2025.100958. eCollection 2025 Jul.

  PMID: 40276115 DERIVED

Related Links

• Fleischmann, M., Dapper, H., Diefenhardt, M. et al. Perkutane Strahlentherapie kombiniert mit endorektaler Brachytherapie zum Organerhalt bei älteren/gebrechlichen Patienten mit Rektumkarzinom - die ACO/ARO/AIO-22-Studie. Onkologie 30, 129-132 (2024). ht

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Emmanouil Fokas, MD DPhil

  University Hospital of Cologne

  STUDY CHAIR

Central Study Contacts

Emmanouil Fokas, MD DPhil

CONTACT

+49 22147898710; emmanouil.fokas@uk-koeln.de

Emmanouil Fokas, MD DPhil

CONTACT

+49 22147884763

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Dr. med. Dr.

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 11, 2024
• Study Start (Estimated): September 30, 2026
• Primary Completion (Estimated): September 30, 2031
• Study Completion (Estimated): December 30, 2031
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Access Criteria: ACO/ARO/AIO-22

Locations

DE (4)