Comparing two radiation treatment approaches for stage II rectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study is a randomized clinical trial involving 131 patients with clinical T2-3 N0 rectal cancer. Participants will be assigned to one of two treatment arms: one receiving standard chemoradiation followed by an external beam radiation boost, and the other receiving the same chemoradiation followed by a brachytherapy boost. The aim is to optimize non-surgical treatment options and achieve complete clinical response, particularly important for older patients with multiple health issues. The study will evaluate the effectiveness of these two radiation dose escalation strategies in preserving the rectum.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Rectal cancer patients, clinically staged as T2-T3a,b N0-1 by MRI or endoscopic/trans-rectal ultrasound
* Rectal cancer staged as N0-1 by MRI or EUS/TRUS
* No metastatic lesion
* Rectal tumor occupying less than half of the circumference
* Tumor less than 5 cm on its largest dimension
* Tumor located at less than 10 cm from the anal verge
* Tumor penetration less than 5 mm in the mesorectal fat
* Tumor accessible for brachytherapy
* Lumen accessible for colonoscopy
* Patient should be a suitable candidate for brachytherapy and chemotherapy
* Older than 18 years of age
* Adequate birth control measures in women of childbearing potential
* Written informed consent

Exclusion Criteria:

* Patients with previous pelvic radiation
* Evidence of distant metastasis
* Extension of malignant disease to the anal canal
* Tumors staged as T4
* Tumors larger than 5 cm in length

Where it's running

• UT Southwestern Medical Center
  Dallas, Texas, United States Recruiting
• Le Centre Hospitalier de l'Université de Montreal
  Montreal, Quebec, Canada Recruiting
• Jewish General Hospital
  Montreal, Quebec, Canada Recruiting
• Centre hospitalier universitaire de Québec
  Québec, Quebec, Canada Recruiting

Study contacts

• Principal investigator: Te Vuong, MD — Sir Mortimer Jewish General Hospital
• Study coordinator: Susanne Knoepfel
• Email: sknoepfel@jgh.mcgill.ca
• Phone: 5143408288

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.