Recruiting nowPhase 3Randomised
| Registry number | NCT06758830 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 3 |
| Design | randomised, blinded |
| Taking part | 400 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Radiotherapy Radiation Therapy
- Drug Chemoradiotherapy
- Drug Consolidation Chemotherapy
- Procedure Surgery
- Other Part two
- Other Adjuvant treatment
What it is measuring
Postoperative complications
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 researchers think total neoadjuvant therapy (chemoradiotherapy followed by chemotherapy) may shrink some rectal cancers to a complete or near-complete clinical response. They are testing whether people with that response can be monitored with a non-operative “watch-and-wait” approach instead of having surgery immediately, while also including a surgery-first comparison group.
The comparison is watch-and-wait after treatment versus initial surgery. The trial measures whether avoiding surgery can reduce postoperative complications while preserving the rectum, without worsening quality of life or survival.
Worth knowing: The randomized group is limited to selected, locally confined rectal cancers, and the main listed outcome is postoperative complications rather than survival itself.
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.
Phase 3. Compares the treatment against current standard care in a large group. This is the design that changes practice.
How the researchers describe it
This study hypothesizes that approximately 50% of rectal cancer patients can preserve their rectum using a watch-and-wait strategy if they achieve a complete or near-complete clinical response to total neoadjuvant therapy (TNT). The objective is to determine whether the complications, quality of life, and survival rates of rectal cancer patients who have achieved a complete or near-complete clinical response to TNT, followed by a watch-and-wait approach, are comparable to those of patients who undergo surgery first. Additionally, the study aims to identify potential prognostic and predictive markers for rectal cancer and examine survival rates and factors influencing responses to chemoradiotherapy (CRT) or TNT.
The study is divided into two parts:
**Part One:** Participants with cT1N1, T2-T3 N0-1 rectal cancer, MRF-, and EMVI-, with surgery as one of the possible first-line treatment options, will be randomized into two groups. The experimental group will consist of participants receiving TNT, including CRT and consolidation chemotherapy (Ch). If these participants achieve a complete or near-complete clinical response, they will be observed using a watch-and-wait strategy, which is a non-operative approach.
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
Part One
Inclusion Criteria
- Over 18 years of age.
- Participants who agreed to participate in the study signed an informed consent form.
- The Eastern Cooperative Oncology Group (ECOG) score ranges from 0 to 2.
- Pathologically confirmed rectal adenocarcinoma.
- Tumor up to 10 cm from the anus.
- Magnetic resonance imaging (MRI) of the pelvis and computed tomography (CT) of the thorax and abdomen were performed to confirm the diagnosis.
- cT1N1, T2-T3 N0 – 1, M0, MRF -, EMVI -.
- Normal bone marrow function: blood leucocytes > 3.5 × 10⁹/l, neutrophils > 1.5 × 10⁹/l, platelets > 100 × 10⁹/l.
- Normal renal function: creatinine within 1,5 × normal.
- Normal liver function: blood bilirubin levels within 1,5 times normal, AST, ALT levels within 2,5 times the upper limit.
Exclusion Criteria
- Prior ST or Ch.
- Participants who are not eligible for pelvic MRI.
- Participants who have had a malignancy in the last 5 years, except for treatment for basal cell or squamous cell skin cancer or in situ cervical cancer.
- ECOG status ≥ 3.
- Distant metastases detected.
- Participants with uncontrolled therapeutic or psychiatric conditions.
- Infectious diseases requiring antibiotic treatment.
Part Two
Inclusion Criteria
- Over 18 years of age.
- Participants who agreed to participate in the study signed an informed consent form.
- ECOG score between 0 and 2.
- Patholo…
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: Lithuania.
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 NCT06758830, registered by National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos 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.