A Phase 2/3 interventional study of Complete responders and Non-complete responders and Chemoradiation + EBRT Boost in Stage II Rectal Cancer, Organ Preservation and Non-operative Treatment, sponsored by Sir Mortimer B. Davis - Jewish General Hospital. Recruiting at 4 sites in 2 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by Sir Mortimer B. Davis - Jewish General Hospital · Phase 2/3, Interventional, and Treatment
A randomized study of 131 patients. Patients with a clinical T2-3 N0-1 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).
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 response. Patients with a clinical T2-3 N0-1 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). Patients that have a high risk of recurrence or with more advanced stages of the disease will be excluded from the study, as only the local disease is being treated. The primary outcome for this proposal is rectum preservation in treated patients.
Exclusion Criteria:
standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy in 5; Complete responders and Non-complete responders
Procedure: Complete responders and Non-complete responders · Radiation: Chemoradiation + EBRT Boost
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; Complete responders and Non-complete responders
Procedure: Complete responders and Non-complete responders · Radiation: Chemoradiation + HDRBT Boost
Patients that are complete responders will not have surgery. Patients that are non-complete responders will have surgery.
45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy in 5
45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and followed by a brachytherapy boost of 30 Gy in 3 fractions
TME-free survival
Time from date of randomization to either TME or death in the intention to treat population
Time frame: 2 years post treatment
Local Recurrence
Number of participants with Local recurrence as assessed by tests during follow-up visits.
Time frame: 2 years post treatment
Disease-free survival
The time between the date of randomization and recurrence, either in the pelvis or metastases. Patients without an event will be censored at the last date the patient was known to be disease-free.
Time frame: 5 years post treatment
Overall survival
The time between date of randomization and date of death due to any causes.
Time frame: 5 years post treatment
Overall Quality of life
Quality of life Questionnaires over different time point
Time frame: 5 years post treatment
Plan to share: No
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Sir Mortimer B. Davis - Jewish General Hospital