NCT04336202

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Sir Mortimer B. Davis - Jewish General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Rectal Cancer
• Comorbidities and Coexisting Conditions
• Inoperable Disease
• Brachytherapy

Interventions

Type	Name	Description
RADIATION	External 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.

Timeline

• Start date: 2024-08-01
• Primary completion: 2025-02-01
• Completion: 2028-01-01
• First posted: 2020-04-07
• Last updated: 2024-03-20

Locations

1 site across 1 country: Canada