Recruiting nowNot phasedRandomised
What this trial is trying to do
The trial asks whether close monitoring after endoscopic removal of an intermediate-risk T1 rectal cancer can control the cancer as well as pelvic radiation plus chemotherapy. The surveillance approach relies on regular examinations and scans to find any regrowth early, rather than treating everyone immediately.
Researchers expect surveillance could avoid serious harms of chemoradiotherapy, including a temporary or permanent ostomy, major bowel problems and other treatment complications, while keeping three-year rates of cancer returning or spreading comparable. The main measure is disease-related treatment failure, alongside serious adverse events over three years.
Worth knowing: This is a randomised comparison in a narrowly defined group: adults with T1 rectal cancer removed endoscopically whose tumour has features linked to a higher risk of cancer remaining nearby; it does not test surveillance for all early rectal cancers.
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 | NCT07669298 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Not phased |
| Design | randomised, open label |
| Taking part | 480 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Medical University of Gdansk |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Other Active surveillance
- Radiotherapy Adjuvant chemoradiotherapy
What it is measuring
Disease-related treatment failure
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 goal of this clinical trial is to learn if close follow-up alone (active surveillance) works as well as radiation combined with chemotherapy (chemoradiotherapy) after removing early rectal cancer in adults. The main questions it aims to answer are:
1. Does active surveillance cause fewer serious adverse events than chemoradiotherapy within 3 years? Serious adverse events include a permanent or temporary ostomy (a surgical opening in the belly to pass stool), major bowel problems, or severe treatment-related complications.
2. Is active surveillance as safe as chemoradiotherapy in preventing cancer from coming back or spreading within 3 years?Researchers will compare active surveillance to chemoradiotherapy to see if surveillance causes fewer serious adverse events while keeping cancer outcomes comparable.
To join this study, participants must be adults who had an early-stage rectal cancer (T1) removed by an endoscopic procedure, and whose removed tumor showed certain features that raise the risk of cancer cells remaining nearby.
Participants will be randomly placed in one of two groups:
1. Active surveillance group: Participants will have regular checkups, blood tests, flexible camera exams of the bowel (rectoscopy), scans of the pelvis and abdomen, and colonoscopy on a set schedule for 5 years. If cancer comes back, doctors will propose further treatment options.
2.Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Rectal
- Colon
- Already treated
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
1. Pathologically confirmed rectal cancer located extraperitoneally.
2. Complete tumour resection (R0) by means of ESD or IMD (endoscopic or TAMIS).
3. Pathological report indicative of:
- pT1 with at least 1 of the following features: poor histological differentiation (grade 3), vascular invasion, lymphatic invasion, high tumour budding (grade 2-3), sm2 or sm3 invasion.
4. Endoscopic images or video of the tumour before local excision.
5. Maximum cancer diameter ≤ 30 mm based on the pathological assessment.
6. cN0 stage based on pelvic MRI; lymph nodes smaller than 10 mm will be considered as benign, independent of morphologic features. Staging must be performed within 6 weeks before randomisation.
- If enlarged lymph nodes are present on MRI performed after ESD/IMD (raising the possibility of reactive inflammatory change), fine needle aspiration (FNA) will be undertaken, and patients with negative FNA cytology will remain eligible.
7. Adequate distant staging (thoracic and abdominal CT) without signs of distant metastasis (cM0).
8. Have undergone a high-quality full colonoscopy:
- Boston Bowel Preparation Scale score equal or greater than 2 in all colonic segments.
- Documented caecal intubation.
- All polyps ≥20 mm in diameter other than the index lesion must be completely removed and assessed pathologically.
9.
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 3 sites. Listed in: France, Poland.
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 NCT07669298, registered by Medical University of Gdansk 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.