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A new radiation combo may spare the rectum in early cancer

NCT ID NCT06501053

Disease control Sponsor: Alexander Valdman 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time

Summary

This trial tests whether a combination of contact X-ray brachytherapy and short-course radiotherapy can preserve the rectum in people with early-stage rectal cancer. Participants receive this experimental radiation regimen, with some also getting chemotherapy. The goal is to see if this approach is as good as standard treatment at avoiding rectal removal while keeping the cancer under control.

What this could mean

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

Active substance
Contact X-ray brachytherapy combined with short-course radiotherapy, with or without capecitabine chemotherapy
What this could lead to
If successful, this approach could offer a non-surgical option to treat early rectal cancer while preserving the rectum, avoiding the need for removal.
What could go wrong
This is a phase II trial, so results are preliminary. The treatment may not be as effective as standard care, and there are risks of toxicity and potential failure requiring 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 110 people

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

Started

Mar 2025

Expected to finish

Nov 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: * Adenocarcinoma of the rectum classified as: * cT1-cT3ab, \< 5 cm largest diameter and \< ½ circumference (MRI staging), N0-N1 (\<= 3 nodes \< 8mm diameter), M0 * Performance status (ECOG) 0-1 * Operable patient * Tumor accessible to endocavitary contact X-ray brachytherapy with a distance from the lower tumor border to the anal verge ≤10 cm * 18 years or above * No comorbidity preventing treatment * Patient having read the information note and having signed the informed consent * Follow-up possible Exclusion Criteria: * Inoperable patient * T3cd, T4, T≥ 5cm, Involvement of more than half of the bowel circumference * Distance from the lower tumor border to the anal verge \>10 cm * N2-status at diagnosis or N1 with any node\>= 8 mm diameter * Patient presenting with metastasis at diagnosis (M1) * Previous pelvic irradiation * Tumor with extramural vascular invasion * Poorly differentiated tumor * Simultaneous progressive cancer * Tumor invading external anal sphincter or growth within 1 mm of the levator * Tumor within 1 mm from MRF (mesorectal fascia) * Patient unable to receive CXB or CRT * Any significant concurrent medical illness that in the opinion of the investigator would preclude protocol therapy * Patient with history of poor compliance or current or past psychiatric conditions or severe acute or chronic medical conditions that would interfere with the ability to comply with the study protocol * Concurrent enrolment in another clinical trial using an investigational anti-cancer treatment within 28 days prior to the first dose of study treatment * Total DPD deficiency

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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 places running it

    2 sites. 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

  • Karolinska University Hospital, Theme Cancer, Dept of Pelvic cancer

    RECRUITING

    Stockholm, Solna, 171 76, Sweden

  • Uppsala University Hospital, Colorectal Surgery

    RECRUITING

    Uppsala, 751 85, Sweden

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