Recruiting nowNot phasedRandomised
| Registry number | NCT04098471 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Not phased |
| Design | randomised, blinded |
| Taking part | 168 people (planned) |
| Who can join | aged 18 Years to 75 Years |
| Run by | The First Affiliated Hospital with Nanjing Medical University |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Procedure transanal local excision following radiotherapy
- Procedure TME
What it is measuring
local recurrance rate
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.
What this trial is trying to do
The trial asks whether radiotherapy followed by transanal endoscopic microsurgery (removing the tumour through the anus) can control T2N0M0 distal rectal cancer as well as total mesorectal excision (TME), which removes the rectum and surrounding tissue. It is testing a treatment sequence and operation rather than a new drug.
The researchers expect local excision after radiotherapy may treat the tumour while avoiding the greater anatomical disruption of TME, potentially preserving bowel function and reducing treatment burden. The main comparison is the rate at which cancer returns in the pelvis; the trial also compares short- and long-term outcomes, but this is not a direct test of longer survival.
Worth knowing: The trial is limited to people with T2N0M0 distal rectal cancer, and its main endpoint is local recurrence rather than overall survival or quality of life.
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.
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
A randomized controlled clinical trial to compare the short and long term outcomes of transanal endoscopic microsurgery following radiotherapy or total mesorectal excision for the treatment of Rectal Cancer
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
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 between 18 and 75 years.
- Histologically confirmed adenocarcinoma by preoperative biopsy.
- Tumor located within 4 cm from the anal verge, confirmed by at least one of the following methods: digital rectal examination, pelvic magnetic resonance imaging (MRI), or colonoscopy.
- Tumor size ≤3 cm, without fixation and with preserved mobility on clinical examination.
- Clinical stage T2 rectal cancer confirmed by preoperative high-resolution pelvic MRI.
- No radiological evidence of suspicious lymph node metastasis or distant metastasis on preoperative contrast-enhanced computed tomography (CT) and MRI.
- Ability to provide written informed consent.
Exclusion Criteria
- History of other malignant tumors within the past 5 years.
- Poorly differentiated adenocarcinoma, mucinous adenocarcinoma, or signet ring cell carcinoma confirmed by pathological examination.
- Multiple primary colorectal tumors.
- Pregnant or breastfeeding women.
- Patients with plans for pregnancy.
- Severe psychiatric disorders.
- Previous treatment for rectal cancer, including radiotherapy or chemotherapy.
- Concomitant intestinal diseases, including familial adenomatous polyposis (FAP), hereditary nonpolyposis colorectal cancer (HNPCC), active ulcerative colitis, or Crohn's disease.
- Poor general condition or uncontrolled serious comorbidities that may affect study participati…
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: China.
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 NCT04098471, registered by The First Affiliated Hospital with Nanjing Medical 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.