New combo radiation therapy aims to spare elderly rectal cancer patients from surgery
NCT ID NCT06729645
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a combination of two types of radiation therapy for elderly or frail patients with rectal cancer who cannot or will not have surgery. The goal is to shrink or control the tumor while maintaining quality of life. Researchers will follow 80 participants for up to two years to see how well the treatment works and how it affects daily living.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- radiation therapy (external beam radiotherapy and endorectal high-dose-rate brachytherapy)
- What this could lead to
- If successful, this approach could offer a non-surgical treatment option that controls rectal cancer and preserves quality of life for elderly or frail patients.
- What could go wrong
- This is an early-phase trial with only 80 participants, so results may not apply to all patients. The treatment may not achieve lasting tumor control, and side effects from radiation are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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70 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Frankfurt Universitätsklinikum
Frankfurt am Main, Hesse, 60590, Germany
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Klinik für Strahlentherapie, Cyberknife und Radioonkologie Universität zu Köln
Cologne, North Rhine-Westphalia, 50937, Germany
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Klinikverbund Allgäu
Kempten, BaBaden-Württembergs, 87439, Germany
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Leipzig, Universitätsklinikum
Leipzig, Saxony, 04103, Germany
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