Status:
RECRUITING
Watch and Wait Management on Rectal Cancer Patients Using New Swift Local Therapy
Lead Sponsor:
Sir Mortimer B. Davis - Jewish General Hospital
Collaborating Sponsors:
Icad, Inc.
Conditions:
Rectal Cancer
Comorbidities and Coexisting Conditions
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 appli...
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, assess...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04336202
Start Date
August 1 2024
End Date
January 1 2028
Last Update
March 20 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2