Actively Recruiting
No Surgery Trial / Two Dose-escalation Strategies
Led by Sir Mortimer B. Davis - Jewish General Hospital · Updated on 2026-02-17
131
Participants Needed
4
Research Sites
662 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A randomized study of 131 patients. Patients with a clinical T2-3 N0 rectal cancer will be randomized to two arms (arm A: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy compared to arm B: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and followed by a brachytherapy boost of 30 Gy in 3 fractions).
CONDITIONS
Official Title
No Surgery Trial / Two Dose-escalation Strategies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Suitable candidate for brachytherapy and chemotherapy
- Older than 18 years of age
- Adequate birth control measures in women of childbearing potential
- Written informed consent
You will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 4 locations
1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
2
Le Centre Hospitalier de l'Université de Montreal
Montreal, Quebec, Canada, H2X0A9
Actively Recruiting
3
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
4
Centre hospitalier universitaire de Québec
Québec, Quebec, Canada, G2L2Z3
Actively Recruiting
Research Team
S
Susanne Knoepfel
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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