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New rectal cancer device tested in elderly patients

NCT ID NCT04336202

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
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tests a new rectal applicator for delivering radiation therapy to elderly patients with inoperable rectal cancer. The treatment combines external beam radiation with three sessions of internal radiation (brachytherapy) using the new device. The study aims to see if the new applicator is safe, feasible, and effective at shrinking tumors, while monitoring for side effects like rectal bleeding or diarrhea.

What this could mean

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

Active substance
External beam radiotherapy and endorectal brachytherapy with a new rectal applicator
What this could lead to
If successful, this new applicator could offer a safer, more effective radiation treatment option for elderly patients with inoperable rectal cancer, potentially improving quality of life and tumor control.
What could go wrong
This is a small, early pilot study with only 45 participants and is currently suspended. The new device may not work better than existing ones, and there is a risk of severe side effects like rectal bleeding or diarrhea.

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 45 people

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

Started

Oct 2020

Expected to finish

Jan 2028

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 with histologic diagnosis by proctoscopic biopsy of invasive rectal adenocarcinoma will be considered for entry in this study. * Patient in whom the diagnosis of invasive rectal cancer has been obtained by incisional biopsy (surgical or endoscopic biopsy) that the majority of the tumor has not been removed . * The tumor should be either palpable by clinical rectal exam or accessible via a rigid proctoscope, and its proximal border should be located no more than 15 cm from the anal verge. * Rectal cancer clinically stage as T2-T3 N1+ by MRI or endoscopic ultrasound. * Tumor of 5 cm or less length, non obstructive * Patient is not suitable for surgery nor chemotherapy due to medical conditions * Patient must consent to be in the study and consent form must be signed, witnessed and dated prior to registration . * Patients must be accessible geographically for follow up. * Adults older than 18 years of age Exclusion Criteria: * Patient with malignant rectal tumors other than adenocarcinoma, i.e, sarcoma, lymphoma, carcinoid, squamous cell, cloacogenic, etc. * Patient who demonstrate prior to randomization, evidence of free perforation, as manifested by free fluid in the abdomen. * Patient who are curable by standard of care with either surgery or eligible for the Morpheus study. * Patient who have received any previous therapy (radiation , chemotherapy) for rectal cancer. * Patient whose tumor is fixed by clinical examination to surrounding structures, precluding the possibility of adequate surgical resection even with pelvic exenteration. * Patient with a performance status of 3 or 4. * Patient with tumor involving the anal canal. * Patient who are pregnant at the time of randomization. * Patient with psychiatric or addictive disorders that would preclude obtaining informed consent. * Patient who have multiple primary tumors involving both the colon and rectum that would preclude them from being classified as having only rectal cancer.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2, Canada

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