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
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
Jewish General Hospital
RECRUITING
Montreal
Contact Information
Primary
Te Vuong, MD
tvuong@jgh.mcgill.ca
514-340-8288
Backup
Luciana Poggi, PhD
luciana.poggi.trinidad.ccomtl@ssss.gouv.qc.ca
514-340-8222
Time Frame
Start Date: 2024-08
Estimated Completion Date: 2028-01
Participants
Target number of participants: 45
Treatments
Other: 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.
Related Therapeutic Areas
Sponsors
Collaborators: Icad, Inc.
Leads: Sir Mortimer B. Davis - Jewish General Hospital

This content was sourced from clinicaltrials.gov