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Breakthrough study aims to spare rectal cancer patients from surgery

NCT ID NCT07483060

Disease control Sponsor: Vastra Gotaland Region Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a targeted chemoradiotherapy can completely eliminate early-stage rectal cancer, allowing patients to avoid surgery and keep their rectum. 90 adults with small, localized tumors will either receive standard surgery or the new treatment followed by close monitoring. The goal is to see if the cancer stays away for at least one year without needing an operation.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 90 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

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: * Age ≥ 18 years * Written informed consent * Biopsy-proven rectal adenocarcinoma * Tumor located \<12 cm from the anal verge * MRI-staged T1-T3b tumor * N0 or NX (no radiologic evidence of nodal metastases) * M0 or MX (no radiological evidence of distant metastases) * ECOG performance status 0-1 * Multidisciplinary team (MDT) assessment confirming that both total mesorectal excision (TME) and chemoradiotherapy are feasible treatment options Exclusion Criteria: * MRI-defined N1 or higher nodal disease * Distant metastases (M1) * MRI extramural vascular invasion (mriEMVI) * Threatened mesorectal fascia (≤1 mm on MRI) * Maximum tumor diameter \> 40 mm * MRI defined mucinous tumor * No residual luminal tumor following prior endoscopic resection * Recurrent rectal cancer * Prior pelvic radiotherapy * Uncontrolled significant cardiorespiratory comorbidity * Known complete dihydropyrimidine dehydrogenase (DPYD) deficiency * Known Gilbert's syndrome * Pregnancy or breastfeeding * Concomitant medication contraindicated with capecitabine that cannot be safely discontinued * Age \<18 years

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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 cancer

How to take part

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

  1. 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 ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.