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Can a less invasive surgery plus radiation match major surgery for rectal cancer?

NCT ID NCT04098471

Disease control Sponsor: The First Affiliated Hospital with Nanjing Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time

Summary

This trial compares two treatments for people with early-stage (T2) rectal cancer located near the anus. One group receives a less invasive procedure called transanal local excision followed by radiotherapy, while the other group undergoes standard major surgery (total mesorectal excision). The goal is to see whether the less invasive approach can achieve similar cancer control and survival rates while possibly offering better quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
transanal local excision following radiotherapy or total mesorectal excision
What this could lead to
If successful, this could show that a less invasive surgery combined with radiotherapy is as effective as major surgery for early rectal cancer, potentially preserving quality of life.
What could go wrong
This is a mid-stage trial with 168 participants, so results may not apply to all patients. The less invasive approach might carry a higher risk of cancer recurrence.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 168 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2021

Expected to finish

Jun 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 participation or treatment. * Contraindications to laparoscopic surgery, including extensive intra-abdominal adhesions caused by previous abdominal surgery or inability to tolerate pneumoperitoneum. * Current participation in another clinical trial.

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Conditions

The condition(s) this trial relates to.

rectal cancer rectal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rectal cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Colorectal Surgery Department, First Affiliated Hospital of Nanjing Medical University

    RECRUITING

    Nanjing, Jiangsu, China

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