Whistle Study

Protocol

Protocol summary:
Some patients are medically unfit for surgery because of other medical issues, old age or because they are simply refusing standard surgery.
Patients are to receive 1-3 weeks of external beam radiation therapy initially alone, then 3 sessions of targeted adaptive endorectal brachytherapy given weekly.
This study explores the use of a novel rectal applicator approved by Health Canada which could considerably reduce the treatment time and provide a more comfortable experience for patients.
The objectives of this study are:
1. Validate the feasibility of using this new applicator in a brachytherapy/radiotherapy setting
2. To evaluate the treatment time required during its use
3. To eventually avoid surgery.
NCT04336202

Inclusion criteria

Eligibility Criteria 

Patients with histologic diagnosis by proctoscopic biopsy of invasive rectal adenocarcinoma will be considered for entry in this study. 
Patient in whom the diagnosis of invasive rectal cancer has been obtained by incisional biopsy (surgical or endoscopic biopsy) that the majority of the tumor has not been  removed. 
The tumor should be either palpable by clinical rectal exam or accessible via a  rigid proctoscope, and its proximal  border should be located no more than 15  cm from the  anal  verge.
Rectal cancer clinically stage as T2-T3 N1+ by MRI or endoscopic ultrasound.
Tumor of 5 cm or less length, non obstructive

 

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

 

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