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New radiation applicator aims to treat rectal cancer without surgery

NCT ID NCT07402486

Disease control Sponsor: Siriraj Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase II trial tests a new device called the Maastro applicator, which delivers high-dose radiation directly to rectal tumors. The goal is to see if it can safely eliminate the cancer and allow patients to avoid major surgery. Twenty adults with rectal cancer will receive this treatment and be closely monitored for tumor response and side effects.

What this could mean

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

Active substance
High-dose-rate brachytherapy via Maastro applicator (radiation)
What this could lead to
If successful, this could offer a non-surgical treatment option for rectal cancer, potentially avoiding the need for a permanent stoma and reducing complications.
What could go wrong
This is a small, early-phase study with only 20 participants. The treatment may not fully eliminate the tumor, and there is a risk of cancer regrowth. Side effects from radiation are possible.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 20 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 2027

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: Age ≥ 18 years at the time of informed consent Histologically confirmed rectal cancer Any T, N, or M stage, provided the primary rectal lesion is suitable for endorectal HDR brachytherapy Tumor characteristics deemed suitable for treatment with the Maastro applicator (per investigator assessment) Rectal lesion accessible for applicator placement and adequate visualization Adequate organ function to undergo sedation/anesthesia and brachytherapy, as judged by the investigator Ability to comply with study procedures, imaging, and scheduled follow-up Written informed consent obtained prior to study participation Exclusion Criteria: Active inflammatory bowel disease with moderate to severe disease activity Uncontrolled proctitis not attributable to tumor involvement Severe anorectal conditions that preclude safe applicator placement (e.g., severe anal stenosis, uncontrolled hemorrhoidal bleeding, severe radiation-induced proctopathy in the target area) Any medical, psychiatric, or social condition that, in the opinion of the investigator, would interfere with safe study participation or interpretation of results

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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 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.