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

Sponsor
University Hospital of Cologne
Study ID
NCT06729645
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
70 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • radiotherapy — OTHER
    External beam radiotherapy and endorectal brachytherapy

Study Details

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 Dates

First listed
Dec 11, 2024
Start date
Sep 30, 2026
Status verified
Apr 2026
Primary completion
Sep 30, 2031
Completion
Dec 30, 2031

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Patients with Rectal cancer
    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.

Primary Outcome Measure

Rate of Clinical Complete Response (cCR) or Near cCR at 12 Months [ Time Frame: 12 Months ]

Central Contacts

  • Emmanouil Fokas, MD DPhil
    +49 22147898710
    [email protected]
  • Emmanouil Fokas, MD DPhil
    +49 22147884763

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