New rectal cancer device tested in elderly patients
NCT ID NCT04336202
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
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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
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About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2020
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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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.
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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
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Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
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