Recruiting nowNot phased
What this trial is trying to do
The researchers think that carefully increasing or optimising the radiation dose could control unresectable locally recurrent rectal cancer for longer when surgery is not possible. The trial is testing several radiotherapy approaches, including stereotactic body radiotherapy (focused high-dose treatment) and hyperfractionated chemo-radiotherapy (smaller doses given more often), to see whether this can be delivered safely.
Current non-operative treatment generally combines systemic therapy with radiotherapy, but the best way to use radiotherapy in this setting is uncertain. The trial will assess whether dose escalation is feasible and safe, and whether it helps control symptoms and the cancer locally; it is not specifically designed to show longer overall survival.
Worth knowing: This is a small, non-randomised feasibility study of 30 people, with no comparison group, so it cannot reliably establish that one approach is better than standard treatment.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT07721181 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Not phased |
| Design | not randomised, open label |
| Taking part | 30 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Heike M.U. Peulen |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Radiotherapy SBRT
- Radiotherapy Hyperfractionated chemo-reirradiation
- Radiotherapy Full-course chemoradiotherapy
What it is measuring
To determine the feasibility of radiotherapy dose-escalation in the non-operative management of patients with unresectable locally recurrent rectal cancer.
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Not phased. Not a drug-phase trial. Often a device, a procedure, or a change in how care is delivered.
How the researchers describe it
The optimal curative-intent management of locally recurrent rectal cancer (LRRC) typically involves multimodality therapy, comprising neoadjuvant therapy and subsequent salvage surgery. However, in patients with unresectable LRRC, where surgical intervention is not feasible, management is limited to non-operative bimodality therapy with systemic therapy and radiotherapy. For this patient group, evidence guiding the optimisation of non-operative management remains limited, particularly regarding strategies to optimise radiotherapy and achieve durable control. In this context, the therapeutic goal is to achieve prolonged local control while minimising treatment-related toxicity. Radiotherapy dose escalation has been proposed as a potential strategy to achieve this balance. However, its feasibility and safety in the non-operative management of unresectable LRRC have not yet been established. As such, this study aims to evaluate the feasibility and safety of this radiotherapeutic approach, and to determine its impact on both symptomatic control and oncological outcomes.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Rectal
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
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 regula…
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 6 sites. Listed in: Netherlands.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT07721181, registered by Heike M.U. Peulen on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.