Within our institution, the principal investigator have acquired expertise in endorectal brachytherapy, a localized treatment for colorectal cancer. Until now a modality which uses an endorectal applicator has been used, which has certain limitations. In the context of this study, a new applicator will be used which is already approved by Health Canada for endorectal brachytherapy, thereby improving the participant's quality of life and optimizing treatment time.
The main goal of this study is to treat patients using external beam radiotherapy followed by endorectal brachytherapy using a new applicator. Validating the feasibility of this new applicator, assessing the treatment time required when using it, the necessary workload required and ultimately avoid the need for surgery are our main priorities. Currently, this option is still experimental, although several patients have been treated with this method during the last ten years. In this pilot study, 45 patients will be recruited, whom have medical conditions (co-morbidities) that make surgery very difficult, or patients that are refusing surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
In this study, all participants will receive a treatment of external beam radiotherapy without chemotherapy, which will be followed by three (3) treatments of endorectal brachytherapy with the new applicator.
Jewish General Hospital
Montreal, Quebec, Canada
RECRUITINGThe feasibility of the new device
To measure the percentage (%) of clinical complete responders versus non-complete clinical responders and compare it to the percentage of an already proven device to determine if the new device can be used to treat rectal cancer patients. The cancer response will be assessed by rectoscopy, biopsy and imaging.
Time frame: 2 years post treatment
Toxicity using the new device
Use the CTCAE guidelines to measure the percentage (%) of toxicity (G3 and above) of this novel X-Ray device. All grade 3 post-treatment complications will be reported (Proctitis, rectal bleeding, diarrhea). The toxicity will be assessed by the clinician during the follow-up visits. An early stopping rule for possible severe toxicity during and post treatment toxicity will be used in this study. The following early stopping rules will be applied to test the null hypothesis that the proportion of severe toxicity is less or equal to 25 % at 0.05: * 3 severe toxicities (G3-4) out of the first 12 evaluable patients or * 5 severe toxicities (G3-4) out of the first 22 evaluable patients or * 7 severe toxicities (G3-4) out of the first 36 evaluable patients.
Time frame: 2 years post treatment
Workload
To evaluate the workload of this modality in regards to time management (the time required to treat patients (pre-treatment and during treatment) and the number of ressources required. The principal investigator will compare it to an already existent equivalent treatment.
Time frame: 2 years post treatment
Tumor response
Number of participants (#) that are complete clinical responders
Time frame: At clinical evaluation, 13 weeks since beginning of treatments
Local control
Number (#) of participants with Local control assessed during follow-up visits
Time frame: 2 years post treatment
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