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No Surgery Trial / Two Dose-escalation Strategies
Sponsor: Sir Mortimer B. Davis - Jewish General Hospital
Summary
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).
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
131
Start Date
2017-04-25
Completion Date
2030-01
Last Updated
2026-02-17
Healthy Volunteers
No
Conditions
Interventions
Complete responders and Non-complete responders
Patients that are complete responders will not have surgery. Patients that are non-complete responders will have surgery.
Chemoradiation + EBRT Boost
45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy in 5
Chemoradiation + HDRBT Boost
45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and followed by a brachytherapy boost of 30 Gy in 3 fractions
Locations (4)
UT Southwestern Medical Center
Dallas, Texas, United States
Le Centre Hospitalier de l'Université de Montreal
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Centre hospitalier universitaire de Québec
Québec, Quebec, Canada