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Studies

Interventional Not yet recruiting

NCT06729645 on ClinicalTrials.gov

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

Official title: 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

  • Sponsor: University Hospital Cologne
  • Enrollment: 80 (Estimated)
  • Study start: 2026-09-30 (Estimated)
  • Primary completion: 2031-09-30 (Estimated)
  • Study completion: 2031-12-30 (Estimated)
  • Allocation: N/a
  • InterventionModel: Single Group
  • Masking: None
  • PrimaryPurpose: Treatment

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

Intervention / Treatment

  • Other: radiotherapy

Primary Outcome Measures

  • Rate of Clinical Complete Response (cCR) or Near cCR at 12 Months (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.

Countries

Germany

Locations and Investigators

  • Klinikverbund Allgäu, Kempten, Germany
    • Florian f Sterzing, Prof. Dr. med.
  • Frankfurt Universitätsklinikum, Frankfurt am Main, Germany
    • Markus M Diefenhardt, PD Dr.
  • Klinik für Strahlentherapie, Cyberknife und Radioonkologie Universität zu Köln, Cologne, Germany
    • Emmanouil E Fokas, Prof. Dr. med. Dr.
  • Leipzig, Universitätsklinikum, Leipzig, Germany
    • Thomas t Kuhnt, Prof. Dr.

Study Officials