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Could skipping surgery be safe for some rectal cancer patients?

NCT ID NCT06328361

Disease control Sponsor: Tampere University Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study is testing whether people with rectal cancer who have a complete response to initial therapy can safely avoid surgery and instead be closely monitored. Researchers will track 200 participants to see how often the cancer stays away or comes back. The goal is to preserve the rectum and avoid the side effects of surgery.

What this could mean

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

Active substance
nonoperative surveillance (watch-and-wait monitoring with exams and scans)
What this could lead to
If successful, this approach could allow many rectal cancer patients to avoid major surgery and its side effects while still keeping the cancer under control.
What could go wrong
This is an early, single-arm study with no comparison group, so results may not apply broadly. There is a risk that the cancer may regrow, requiring delayed surgery.

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 200 people

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

Started

May 2024

Expected to finish

Dec 2032

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 years and older

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: * Histopathological verification of primary rectal adenocarcinoma * Complete clinical response at response assessment after neoadjuvant therapy * Informed consent to organ preservation study Exclusion Criteria: * Evidence of metastatic disease (fulfilling M-class criteria of TNM) * No neoadjuvant therapy * Inability to understand the information related to harms and benefits

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Conditions

The condition(s) this trial relates to.

rectal cancer rectal neoplasm rectum adenocarcinoma

As listed by the trial registrant

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

Rectal adenocarcinoma 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

    13 sites in 2 countries. 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

  • East Tallinn Central Hospital

    RECRUITING

    Tallinn, Estonia

  • Helsinki University Central Hospital

    RECRUITING

    Helsinki, 00290, Finland

  • Jyväskylä Central Hospital

    RECRUITING

    Jyväskylä, Finland

  • Kuopio University Hospital

    RECRUITING

    Kuopio, Finland

  • North Estonia Medical Centre

    RECRUITING

    Tallinn, Estonia

  • Oulu University Hospital

    RECRUITING

    Oulu, Finland

  • Satakunta Central Hospital

    RECRUITING

    Pori, Finland

  • Seinajoki Central Hospital

    RECRUITING

    Seinäjoki, Finland

  • Tampere University Hospital

    RECRUITING

    Tampere, 33400, Finland

  • Tartu University Hospital

    RECRUITING

    Tartu, Estonia

  • Turku University Hospital

    RECRUITING

    Turku, Finland

  • Vaasa Central Hospital

    NOT_YET_RECRUITING

    Vaasa, 65100, Finland

  • West Tallinn Central Hospital

    RECRUITING

    Tallinn, Estonia

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