Can stronger radiation tame inoperable rectal cancer without surgery?
NCT ID NCT07721181
First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time
Summary
This trial investigates whether giving a higher dose of radiotherapy can safely control locally recurrent rectal cancer that cannot be surgically removed. Around 30 adults with this condition will receive either stereotactic body radiotherapy or hyperfractionated chemo-reirradiation. The goal is to see if this approach is feasible and keeps the cancer in check while limiting side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- radiotherapy dose escalation (SBRT or hyperfractionated chemo-reirradiation)
- What this could lead to
- If successful, this approach could offer a non-surgical way to control locally recurrent rectal cancer, potentially improving symptom control and delaying disease progression.
- What could go wrong
- This is a small feasibility study, not a large trial. Higher radiation doses carry a risk of serious side effects, and it is unclear whether the benefits will outweigh the risks.
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
-
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
-
About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Sep 2026
An estimate. Start dates often move.
- Expected to finish
-
Dec 2031
An estimate. End dates often move.
- Lead sponsor
-
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
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
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: * Age ≥ 18 years old. * Diagnosis of locally recurrent rectal cancer, defined as recurrent disease within the pelvis after surgical excision for primary rectal or distal sigmoidal cancer, diagnosed either by histopathology or clinically proven (evidence on imaging in combination with clinical findings, with consensus in MDT). A second recurrence is eligible if (chemo-)reirradiation is considered feasible, with consensus in MDT. * Recurrent disease is determined as unresectable where surgery has been ruled out by clinicians (or refused by patient), with consensus in MDT. Unresectable is defined as: expected gross incomplete resection with overt tumour remaining in the patient after resection, encasement of the ischiadic nerve and invasion of the cortex and/or neuroforamina from S2 and upwards. \- Either radiological absence of distant metastatic disease (M0), or, with (oligo)metastatic disease that does not require imminent start of systematic therapy at time of inclusion. If systematic chemotherapy was previously administered prior to inclusion, and there is a current indication for local treatment with radiotherapy, patients are still eligible. * WHO/ECOG performance score 0-2. * MR pelvis and thoracoabdominal CT with interpretation no longer than 6 weeks prior to inclusion. * Written informed consent according to the ICH-GCP and national/local regulations. Exclusion Criteria: * Radiological evidence of extensive metastatic disease (e.g., extensive liver or lung metastases) at time of inclusion, that requires imminent start of systemic therapy, with consensus in MDT. * Radiotherapy in the past 6 months. * Any contraindication for planned radiotherapy dose escalation, as determined by the radiation oncologist (e.g., residual grade 3 toxicity from previous radiotherapy). * Administration of bevacizumab/panitumumab/cetuximab \<6 weeks prior to start radiotherapy dose escalation. * Severe active morbidity, concomitant disease or active infections. * dMMR/MSI status
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Locally recurrent rectal cancer are added.
By submitting, you agree to our Terms of use
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.
-
The places running it
5 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
Catharina Hospital
RECRUITINGEindhoven, Netherlands
-
Erasmus Medical Centre
NOT_YET_RECRUITINGRotterdam, Netherlands
-
Radiotherapiegroep
NOT_YET_RECRUITINGArnhem, Netherlands
-
Rijnstate
NOT_YET_RECRUITINGArnhem, Netherlands
-
University Medical Centre Utrecht
NOT_YET_RECRUITINGUtrecht, Netherlands
More trials for these conditions
Other studies related to the condition(s) this trial covers.