The purpose of this trial is to improve the management of patients with potentially surgically curable colorectal cancer liver metastases. The primary objective is to determine the impact of pre-operative positron emission tomography (PET) on patients who have been assessed as having resectable colorectal cancer liver metastases by conventional imaging (computed tomography (CT) abdomen/thorax, colonoscopy), by determining the proportion of patients who have a change in management resulting from PET.
Colorectal cancer remains a leading cause of death in men and women. A significant number of patients with colorectal cancer will either present with, or subsequently develop, liver metastases. In contrast to many other epithelial solid tumours, resection of colorectal cancer hepatic metastases results in long-term survival and even cure. However, despite state of the art CT imaging, 60-75% of patients who appear to have limited disease amenable to surgical resection will eventually die from extra-hepatic and recurrent hepatic metastases. If occult micrometastatic disease that becomes evident after liver resection could be detected reliably during pre-operative assessment, patients harboring more widespread disease could be spared a non-curative liver resection. This is one of the present challenges of liver surgery. PET imaging has the potential to improve the detection of both hepatic and extra-hepatic metastatic disease, not detected by conventional imaging modalities. This prospective, multicenter trial will enroll patients with colorectal cancer liver metastases considered resectable, based on CT scans of the thorax, abdomen and pelvis, which demonstrate no evidence of extra-hepatic disease. A full colonoscopy within the preceding 12 months will ensure there is no local recurrence, or other primary cancer at the time of planned liver resection. These patients will be randomized to PET scan or not.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
404
PET diagnostic imaging
Hamilton Health Sciences
Hamilton, Ontario, Canada
St. Joseph's Healthcare
Hamilton, Ontario, Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada
Grand River Regional Cancer Centre
Kitchener, Ontario, Canada
London Health Sciences
London, Ontario, Canada
The Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
St. Joseph's Health Centre
Toronto, Ontario, Canada
proportion of patients who have a change in management resulting from PET
Time frame: 12 months
proportion of patients precluded from having a liver resection because of additional metastatic disease identified on PET
Time frame: 12 months
3-year overall survival of patients who undergo surgery with curative intent
Time frame: 12 months
3-year overall survival of all patients
Time frame: 12 months
sensitivity and specificity of PET in detecting other hepatic and extra-hepatic metastatic disease prior to a potentially curable liver resection for colorectal adenocarcinoma metastatic disease
Time frame: 12 months
economic analysis of the addition of PET in the diagnostic work-up
Time frame: 4 year
prognostic ability of the PET standard uptake value (SUV) in predicting 3-year overall survival
Time frame: 12 months
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