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New trial aims to save rectums in rectal cancer patients

NCT ID NCT06952101

Disease control Sponsor: Fondazione del Piemonte per l'Oncologia 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 1 time

Summary

This study tests a personalized, stage-based approach to treat rectal cancer while trying to avoid removing the rectum. 200 participants will receive either experimental chemoradiotherapy or minimally invasive surgery depending on their cancer stage. The goal is to preserve the rectum and improve quality of life without compromising cancer control.

What this could mean

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

Active substance
chemoradiotherapy (experimental and standard), minimally invasive surgery (laparoscopic/robotic)
What this could lead to
If successful, this could offer a way to treat rectal cancer without removing the rectum, preserving bowel function and quality of life for many patients.
What could go wrong
This is an early-phase study with only 200 participants, so results may not apply to everyone. The organ-sparing approach may not work for all patients, and some may still need surgery or face 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 200 people

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

Started

Apr 2024

Expected to finish

Dec 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 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: * Patients aged ≥18 yrs old * Patients able to sign the informed consent * Patients with High Risk pT1 rectal adenocarcinoma endoscopically excised * Patients with cT2-3aN0 rectal adenocarcinoma who has complete/major response to EXPERIMENTAL CRT * Patients with cT3b4N0-1 rectal adenocarcinoma who has complete/major response to STANDARD CRT Exclusion Criteria: * cT2-4 any NM0 who don't reach cCR or cMR after experimental/standard CRT * Pregnancy

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Conditions

The condition(s) this trial relates to.

rectal neoplasm rectum adenocarcinoma

As listed by the trial registrant

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

Non metastatic Rectal adenocarcinoma

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

  • Department of Surgical Oncology - FPO-IRCCS Institute for Cancer Research and Treatment

    RECRUITING

    Candiolo, Turin, 10060, Italy

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