Research protocol
Protocol summary:
For patients with curable and operable rectal cancer, it has been shown that patients who had a complete response (tumor disappearing) after standard chemoradiation treatments could avoid or delay surgery safely.
This study is exploring two non-operative treatment strategies using dose escalation either with external beam radiation (Arm A) or targeted endorectal brachytherapy (Arm B). Patients are randomly assigned to either arm A or Arm B.
For both arms, after treatment, if the tumor disappears, there is no surgery. If the tumour is still present, standard surgery will be done.
The objectives are to evaluate which of the two strategies is best to achieve the highest rate of tumour disappearance allowing for a non-surgical cure.
NCT03051464
Rectal cancer patient, clinically staged as T2-T3 by MRI or endoscopic/transrectal ultrasound
Rectal cancer staged as N) by MRI or EUS/TRUS
No metastatic lesion
Rectal tumor occupying less than half of the circumference
Tumour length less than or equal to 5cm
Tumor located at less than 10cm from the anal verge
Tumor penetration less than 5mm in the mesorectal fat
Tumor accessible for brachytherapy
Operable patients who would like to avoid surgery
Lumen accessible for colonoscopy
Patient should be a suitable candidate for brachytherapy and chemotherapy
Older than 19 years of age
Adequate birth control measures in women of childbearing potential
Written informed consent
For more information, please contact:
Alix Legrand – Clinical Research Associate
alix.legrand.ccomtl@ssss.gouv.qc.ca
T: 514-340-8222 ext. 28443
Aubrée Brodin – Clinical Research Associate
aubrée.brodin.ccomtl@ssss.gouv.qc.ca
T: 514-340-8222 ext. 26199