Recruiting nowNot phasedRandomised
What this trial is trying to do
The researchers are testing whether adding contact X-ray brachytherapy (CXB), which delivers radiation directly to the rectal tumour, to short-course radiotherapy can control early or early-intermediate rectal cancer while preserving the rectum. The treatment is being studied in people with cT1–3abN1 disease, meaning a tumour that has not grown deeply through the rectal wall but may involve nearby lymph nodes.
The trial asks whether this approach preserves the rectum at least as often as the experimental treatment used in the OPERA trial. The main measure is rectum preservation, rather than simply shrinking the tumour or extending survival.
Worth knowing: This is a phase 2 non-inferiority study: it is testing whether rectum preservation is not unacceptably worse than the comparison treatment, and the record does not describe a survival endpoint.
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 | NCT06501053 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Not phased |
| Design | randomised, open label |
| Taking part | 110 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Alexander Valdman |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Radiotherapy Radiotherapy
- Radiotherapy Short-course radiotherapy
- Radiotherapy Contact x-ray brachytherapy
- Drug Chemotherapy
What it is measuring
Rectum preservation
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 aim of the CORRECT phase 2 study is to show non-inferiority of Contact x-ray brachytherapy (CXB) + short-course radiotherapy (SCRT) compared to the experimental arm of the OPERA trial in organ preservation for early and early intermediate rectal cancer (cT1-3abN1).
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
- Adenocarcinoma of the rectum classified as:
- cT1-cT3ab, < 5 cm largest diameter and < ½ circumference (MRI staging), N0-N1 (<= 3 nodes < 8mm diameter), M0
- Performance status (ECOG) 0-1
- Operable patient
- Tumor accessible to endocavitary contact X-ray brachytherapy with a distance from the lower tumor border to the anal verge ≤10 cm
- 18 years or above
- No comorbidity preventing treatment
- Patient having read the information note and having signed the informed consent
- Follow-up possible
Exclusion Criteria
- Inoperable patient
- T3cd, T4, T≥ 5cm, Involvement of more than half of the bowel circumference
- Distance from the lower tumor border to the anal verge >10 cm
- N2-status at diagnosis or N1 with any node>= 8 mm diameter
- Patient presenting with metastasis at diagnosis (M1)
- Previous pelvic irradiation
- Tumor with extramural vascular invasion
- Poorly differentiated tumor
- Simultaneous progressive cancer
- Tumor invading external anal sphincter or growth within 1 mm of the levator
- Tumor within 1 mm from MRF (mesorectal fascia)
- Patient unable to receive CXB or CRT
- Any significant concurrent medical illness that in the opinion of the investigator would preclude protocol therapy
- Patient with history of poor compliance or current or past psychiatric conditions or severe acute or chronic medical conditions that would interfere wi…
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 2 sites. Listed in: Sweden.
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 NCT06501053, registered by Alexander Valdman 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.