Recruiting nowNot phasedRandomised
What this trial is trying to do
The researchers are testing whether radiotherapy given before surgery (neoadjuvant radiotherapy), followed by removal of the rectum and surrounding tissue in a total mesorectal excision, can control locally advanced proximal rectal cancer better than surgery first. The treatment sequence is intended to destroy cancer cells near the tumour before surgery.
Compared with upfront surgery, the trial asks whether preoperative radiotherapy lowers the rate of cancer returning in the pelvis, its main measure, and whether it also improves disease-free survival, overall survival, and bowel, urinary, and sexual function. It does not establish that radiotherapy is better; it is measuring whether these outcomes differ between the two approaches.
Worth knowing: This is a single-centre study in the narrower group of people with locally advanced proximal rectal cancer, and its main endpoint is local recurrence rather than survival.
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 | NCT07802197 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Not phased |
| Design | randomised, blinded |
| Taking part | 100 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Istanbul University |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Radiotherapy radiotherapy
- Procedure surgery
What it is measuring
Locally Recurrance
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 PRELUDE Study: A Prospective Cohort Study Comparing Neoadjuvant Radiotherapy Followed by Total Mesorectal Excision Versus Upfront Surgery in Patients with Locally Advanced Proximal Rectal Cancer
The PRELUDE Study is a single-center, prospective cohort study designed to compare neoadjuvant radiotherapy followed by total mesorectal excision (TME) with upfront surgery alone in patients with locally advanced proximal rectal cancer.
The primary endpoint is the rate of local recurrence. Secondary endpoints include overall survival, disease-free survival, and functional outcomes related to bowel, urinary, and sexual function.
The aim of this study is to determine whether neoadjuvant radiotherapy reduces the risk of local recurrence and improves long-term oncological and functional outcomes in this anatomically distinct subgroup of patients with rectal cancer.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Locally advanced
- 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
- Locally Advanced Proximally Rectal Cancer
Exclusion Criteria
- Distant metastasis
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 1 site. Listed in: Turkey (Türkiye).
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 NCT07802197, registered by Istanbul University 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.