Recruiting nowNot phasedRandomised
What this trial is trying to do
The trial asks whether giving consolidation chemotherapy after chemoradiation but before surgery can control microscopic cancer earlier than the usual sequence. It compares this treatment order with standard chemoradiation followed by surgery and then postoperative chemotherapy.
The researchers are testing whether the preoperative sequence improves disease-free survival—the time people remain without detectable cancer or recurrence—compared with the standard sequence. The trial is not designed to show a benefit in overall survival directly.
Worth knowing: This is a relatively small randomised trial of 84 people, and disease-free survival is not the same as living longer.
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 | NCT05496491 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Not phased |
| Design | randomised, open label |
| Taking part | 84 people (planned) |
| Who can join | aged 18 Years to 80 Years |
| Run by | Larissa University Hospital |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Radiotherapy Neoadjuvant Chemoradiotherapy
- Drug Adjuvant Chemotherapy
- Drug Consolidation Chemotherapy
What it is measuring
Disease Free Survival
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 purpose of this protocol is to compare neoadjuvant chemoradiation plus consolidation chemotherapy before surgical resection with the standard neoadjuvant chemoradiation followed by surgical resection and adjuvant chemotherapy in patients with rectal cancer.
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
- Histologically confirmed rectal adenocarcinoma
- cT3, cT4, threatened CRM / MRF, EMVI (+), ≥N1
- Multidisciplinary tumor board decision for neoadjuvant treatment
- Tumor distance from the anal verge <15 cm based on endoscopy or magnetic resonance imaging
- Patient 18 to 80 years old
- General health condition status WHO 0-1
- Absence of co-morbidities that may affect treatment
- Neutrophils >1,500 / mm3, platelets >100,000 / mm3, hemoglobin> 10 g / dL, normal creatinine, and creatinine clearance> 50 mL / min
- Signed informed consent of the patient
Exclusion Criteria
- Distant metastases
- Non-resectable cancer
- Contraindications for the administration of chemotherapy
- Previous pelvic radiotherapy or chemotherapy
- History of inflammatory bowel disorders
- History of angina, acute myocardial infarction or heart failure
- Active sepsis or systemic infection
- Untreated physical and mental disability
- Synchronous malignancy
- Pregnancy or breast-feeding
- Lack of compliance with the protocol process
- Non-granting of signed informed consent
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: Greece.
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 NCT05496491, registered by Larissa University Hospital 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.