Neoadjuvant Chemotherapy, Excision and Observation for Early Rectal Cancer: The NEO Trial
Scope: To evaluate the use of neoadjuvant chemotherapy followed by minimally invasive local excision for patients with early stage rectal cancer.
Background: The current treatment for patients with early stage rectal cancer is a radical resection which involves removal of the rectum. This surgery, even when done laparoscopically, has significant rates of complications leading to ongoing issues of bowel function, incontinence, sexual function, and depression. Furthermore, preoperative radiation increases wound healing complications.The study explores the use of organ preservation for patients who show a tumor down staging to T0/T1 N0 to neoadjuvant chemotherapy. This can lead to better outcomes and higher quality of life. Currently there is no prospective experience of neoadjuvant chemotherapy and excision of early rectal tumors.
Objective: The primary objective of the NEO Trial is to determine the rate of organ preservation in patients with early rectal cancer treated with neoadjuvant chemoratherpy follow by local excision, defined as the proportion of paitents with tumor down staging to T0/T1 N0 to the number of patients who avoided radical resection.
Non-operative Management for Locally Advanced Rectal Cancer: The NOM Study
Scope: To evaluate the safety of non-operative management (NOM) in patients with low rectal cancer who acheive a complete clicnical response following chemoradiotherapy.
Background: The standard treatment for low rectal cancer involving the anal sphincter is combined pre-operative chemotherapy and radiotherapy followed by surgery. Because of the high morbidtiy of surgery, there has been increasing interest in NOM of low rectal cancer. The NOM approach involves deferral of surgery and active surveillance of all low rectal cancer patients who achieved a complete clinical response following chemoradiotherapy, which occurs in approximately 20% of patients. To date, while there have been a few, prospective single institution studies that have shown favourable results with NOM, this approach has not been adopted into clinical practice due to concerns from physicians about the safety of NOM based on the limited evidence available. Furthermore, widespread adoption of NOM has the potential to increase health care capacity and decrease treatment costs by reducing the number of surgeries, hospital admissions and costs associated with both surgery and long term surgical morbidity.
Objective: This is a phase II study to evaluate the safety of NOM in low rectal cancer patients. There will be 90 participants across all sites.
Prospective analysis of postoperative morbidity, quality of life and functional outcome after Transanal Total Mesorectal Excision (TaTME Database)
Scope: This is an international, multi-site prospective registry that can capture results on TaTME procedures.
Background: TaTME is a relatively new surgical approach pioneered to tackle difficult pelvic dissections. This operation requires advanced surgical skills and transanal experience, and is currently not performed at every hospital. Its adoption is however rapidly increasing. Outcomes from any new procedure should be monitored and reviewed in order to ensure that the technique is introduced safely and does not lead to inappropriate patient harm. Hence the need for a registry that can capture results on TaTME from multiple centers around the world. This will allow more reliable analysis of larger patient series from the wider surgical community.
Objective: The anticipated benefit of the TaTME database is to provide information of the benefits and potential risks associated with this technique in order to allow a more informed consenting process with the patients. Long-term results will also be analyzed with the aim of providing patients with better functional results and improved quality of life.
Canadian Colorectal Cancer Consortium
Scope: To establish a high-risk colorectal cancer (CRC) registry throughout Canada by collecting data and biospecimens on individuals with newly diagnosed CRC under the age of 60.
Background: This study will look at the genetic components of CRC, including screening for a well-known hereditary CRC condition, Lynch Syndrome. Relatives of CRC patients will also be invited to participate in the study to analyze colonoscopy participation rates, and DNA from high risk families who are not found to have a known hereditary cancer syndrome will provide an invaluable resource for CRC gene discovery studies using next-generation sequencing.
Objective: Through this study, we are hoping to improve screening programs and increase colonoscopy rates in high-risk individuals. Furthermore, the potential identification of novel genes associated with hereditary CRC could provide opportunities for better screening and early detection of CRC in at-risk individuals and improve survival in the second leading cause of cancer death in Canada
Cook Myosite – Gastrointestinal Fecal Incontinence (GIFI)
Scope: To test the safety and feasibility of Autologous Muscle Derived Cells (AMDC) as a treatment for fecal incontinence in men and women. AMDC therapy seeks to allow remodeling of the anal sphincter in patients with fecal incontinence from either defined structural defects to, or a generalized weakening of, the anal sphincter.
Background: This treatment is hypothesized to reduce symptoms of fecal incontinence and improve patient quality of life by strengthening the anal sphincter muscle. The procedure uses Cook MyoSite Incorporated AMDC. AMDC are muscle progenitor cells isolated from a patient’s skeletal muscle. The tissue is collected from a muscle biopsy done on the patient’s thigh and sent to the manufacturer for processing. The resulting cells are sent back to the physician who injects the cells into the patient’s anal sphincter in an outpatient procedure using a small needle under direct vision. Endoanal ultrasound may be used at the physician’s discretion to visualize the location of the injection needle within the anal sphincter.
Objective: The study is a prospective nonrandomized study and will treat a total of 50 patients. The primary objective is to determine the incidence of product or procedure related adverse events associated with the use of AMDC. The secondary outcome objectives are to study the effect of AMDC treatment for fecal incontinence. Patients will be followed for 12 months.
CPAC Rectal Cancer Project
Scope: The Canadian Partnership Against Cancer (CPAC) Rectal Cancer Project is a multi-year project designed to improve the clinical outcomes for patients by implementing quality initiatives for rectal cancer across Canada.
Background: The implementation of these quality initiatives will be evaluated using a set of quality indicators developed for the study, which report the level at which these quality indicators are achieved. Additional site specific knowledge translation strategies will be used to further enhance the implementation of these quality initiatives at each individual site.
Objective: This project is highly relevant as successful widespread implementation of these quality initiatives will lead to improved and more standardized rectal cancer care and set a national standard for these quality initiatives across Canada.
(Detection and Neurological impact of cerebroVascular events In noncardiac Surgery PatIents: A cOhort evaluatioN Study)
Scope: The NeuroVISION Study is a multicentre prospective cohort study, which will enroll 1500 patients who are ≥65 years of age and are anticipated to require a ≥2 night hospital stay after noncardiac surgery.
Background: Covert (minor) strokes occur in a small sample of the population (~0.5%) undergoing surgery. Many of these strokes go undetected as they occur without symptoms.
This study is seeking to identify the incidences as well as the long term impacts of these covert strokes. We will determine the incidence of acute covert stroke using an MRI study of the brain in the days following noncardiac surgery.
Objective: The primary objective of the NeuroVISION study is to characterize the impact of postoperative covert stroke on neurocognitive function one year after elective noncardiac surgery.