Watch and Wait Management on Rectal Cancer Patients Using New Swift Local Therapy (Whistle)
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
Suspended
Issues with applicator
Listed as NCT04336202, this observational or N/A phase trial focuses on Brachytherapy and Comorbidities and Coexisting Conditions and remains suspended. Sponsored by Sir Mortimer B. Davis - Jewish General Hospital, it has been updated 13 times since 2020, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.
Study Description(click to expand)The main goal of this study is to treat patients using external beam radiotherapy followed by endorectal brachytherapy using a new applicator. Validating the feasibility of this new applicator, assessing the treatment time required when using it, the necessary workload required and ultimately avoid the need for surgery are our main priorities. Currently, this option is still experimental, although several patients have been treated with this method during the last ten years.
In this pilot study, 45 patients will be recruited, whom have medical conditions (co-morbidities) that make surgery very difficult, or patients that are refusing surgery.
The main goal of this study is to treat patients using external beam radiotherapy followed by endorectal brachytherapy using a new applicator. Validating the feasibility of this new applicator, assessing the treatment time required when using it, the necessary workload required and ultimately avoid the need for surgery are our main priorities. Currently, this option is still experimental, although several patients have been treated with this method during the last ten years.
In this pilot study, 45 patients will be recruited, whom have medical conditions (co-morbidities) that make surgery very difficult, or patients that are refusing surgery.
Status Flow
Change History
13 versions recorded-
Apr 28, 2026 — Present [daily]
Suspended
Status: Recruiting → Suspended · Phase: NA → None
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Sep 2024 — Apr 2026 [monthly]
Recruiting NA
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Jul 2024 — Sep 2024 [monthly]
Recruiting NA
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Apr 2024 — Jul 2024 [monthly]
Recruiting NA
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Jun 2023 — Apr 2024 [monthly]
Recruiting NA
▶ Show 8 earlier versions
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Nov 2022 — Jun 2023 [monthly]
Recruiting NA
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Jun 2022 — Nov 2022 [monthly]
Recruiting NA
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Mar 2022 — Jun 2022 [monthly]
Recruiting NA
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Jan 2022 — Mar 2022 [monthly]
Recruiting NA
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Dec 2021 — Jan 2022 [monthly]
Recruiting NA
Status: Not Yet Recruiting → Recruiting
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Apr 2021 — Dec 2021 [monthly]
Not Yet Recruiting NA
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Jan 2021 — Apr 2021 [monthly]
Not Yet Recruiting NA
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May 2020 — Jan 2021 [monthly]
Not Yet Recruiting NA
First recorded
Eligibility 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.
Contact Information
- Sir Mortimer B. Davis - Jewish General Hospital
For direct contact, visit the study record on ClinicalTrials.gov .