New local therapy for managing rectal cancer without surgery

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

This study is testing a new treatment for rectal cancer that combines radiation therapy with a special device for patients who can't have surgery or choose not to, to see if it can improve their quality of life.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 45 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sir Mortimer B. Davis - Jewish General Hospital (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Montreal, Quebec)
• Trial ID: NCT04336202 on ClinicalTrials.gov

What this trial studies

This study aims to treat rectal cancer patients using a combination of external beam radiotherapy and a new endorectal brachytherapy applicator. The focus is on patients who cannot undergo surgery due to comorbidities or those who refuse surgical options. The study will assess the feasibility of the new applicator, treatment time, and overall workload while aiming to improve patients' quality of life. A total of 45 patients will be recruited for this pilot study to evaluate the effectiveness of this innovative approach.

Who should consider this trial

Good fit: Ideal candidates include adults with invasive rectal adenocarcinoma who are not suitable for surgery or chemotherapy due to medical conditions.

Not a fit: Patients with malignant rectal conditions that are not eligible for this specific treatment approach may not benefit.

Why it matters

Potential benefit: If successful, this treatment could provide a non-surgical option for rectal cancer patients, improving their quality of life.

How similar studies have performed: While this approach is still experimental, previous treatments using endorectal brachytherapy have shown promise over the last decade.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Montreal, Quebec

• Jewish General Hospital — Montreal, Quebec, Canada (RECRUITING)

Study contacts

• Principal investigator: Te Vuong, MD — Sir Mortimer B. Davis - Jewish General Hospital
• Study coordinator: Te Vuong, MD

Conditions: Rectal Cancer, Comorbidities and Coexisting Conditions, Inoperable Disease, Brachytherapy