Comparing two radiation treatment approaches for stage II rectal cancer
A Phase III Study Testing Two Dose Escalation Strategies to Increase the Population of Complete Responders After Radiation Therapy in the Context of Organ Preservation for Patients With Rectal Cancer
This study is testing two different ways of giving radiation treatment to see which one helps older patients with stage II rectal cancer better avoid surgery and keep their rectum.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 131 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Sir Mortimer B. Davis - Jewish General Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 4 sites (Dallas, Texas and 3 other locations) |
| Trial ID | NCT03051464 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with clinically staged T2-3 N0 rectal cancer who meet specific tumor size and location criteria.
Not a fit: Patients with advanced disease stages, distant metastasis, or those who have previously undergone pelvic radiation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-surgical treatment option that preserves the rectum for patients with stage II rectal cancer.
How similar studies have performed: Other studies have shown promise in optimizing non-surgical approaches for rectal cancer, making this a relevant and potentially impactful investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Rectal cancer patients, clinically staged as T2-T3 by MRI or endoscopic/trans-rectal ultrasound * Rectal cancer staged as N0 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 this trial is running
Dallas, Texas and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.