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
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).
Description
It is becoming clear that there is a now an international consensus that rectal cancer research efforts need to be more focused in optimizing a non-surgical approach. This concept is very relevant to an ageing patient population with multiple co-morbidities regularly seen at the Jewish General Hospital and across the province. After interim analysis on 40 patients of the pilot study a phase III study is proposed. We are therefore proposing a phase III multicentric study of 145 patients to compare the two best known radiation dose escalation strategies and to achieve a complete clinical respons…
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
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 b…
Interventions
- ProcedureComplete responders and Non-complete responders
Patients that are complete responders will not have surgery. Patients that are non-complete responders will have surgery.
- RadiationChemoradiation + EBRT Boost
45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy in 5
- RadiationChemoradiation + 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 CenterDallas, Texas
- Le Centre Hospitalier de l'Université de MontrealMontreal, Quebec
- Jewish General HospitalMontreal, Quebec
- Centre hospitalier universitaire de QuébecQuébec, Quebec