RecruitingNot ApplicableNCT04336202

Watch and Wait Management on Rectal Cancer Patients Using New Swift Local Therapy

A Pilot Study of Dose-escalation Strategy of Radiotherapy Followed by Endorectal Brachytherapy With the Use of a New Rectal Applicator in Inoperable, Ederly Rectal Cancer Patients


Sponsor

Sir Mortimer B. Davis - Jewish General Hospital

Enrollment

45 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Within our institution, the principal investigator have acquired expertise in endorectal brachytherapy, a localized treatment for colorectal cancer. Until now a modality which uses an endorectal applicator has been used, which has certain limitations. In the context of this study, a new applicator will be used which is already approved by Health Canada for endorectal brachytherapy, thereby improving the participant's quality of life and optimizing treatment time.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a 'watch and wait' approach — combined with a focused local radiation treatment — for people with rectal cancer who cannot safely undergo surgery or chemotherapy due to other health conditions. Instead of surgery, researchers are monitoring whether the cancer responds to local treatment and remains stable. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with rectal adenocarcinoma (a specific type of rectal cancer) confirmed by biopsy - Your tumor is accessible via a rectal exam or scope, located within 15 cm of the anus - Your cancer is stage T2–T3 with possible lymph node involvement - Your tumor is 5 cm or smaller and is not blocking the bowel - You are not a candidate for standard surgery or chemotherapy due to your health **You may NOT be eligible if...** - Your cancer type is not rectal adenocarcinoma (e.g., sarcoma, lymphoma) - You have evidence of cancer perforating through the bowel - You have already received radiation or chemotherapy for rectal cancer - Your tumor is fixed to surrounding structures and cannot be treated locally - You are eligible for standard surgery or another clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONExternal beam radiotherapy + Endorectal brachytherapy

In this study, all participants will receive a treatment of external beam radiotherapy without chemotherapy, which will be followed by three (3) treatments of endorectal brachytherapy with the new applicator.


Locations(1)

Jewish General Hospital

Montreal, Quebec, Canada

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NCT04336202


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