Impact of Positron Emission Tomography Imaging Prior to Liver Resection for Colorectal Adenocarcinoma Metastases (PETCAM)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer Liver Metastases |
Procedure: PET diagnostic imaging |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | The Impact of Positron Emission Tomography (PET) Imaging Prior to Liver Resection for Colorectal Adenocarcinoma Metastases: A Prospective, Multicentre Randomized Clinical Trial |
- proportion of patients who have a change in management resulting from PET [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- proportion of patients precluded from having a liver resection because of additional metastatic disease identified on PET [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- 3-year overall survival of patients who undergo surgery with curative intent [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- 3-year overall survival of all patients [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- economic analysis of the addition of PET in the diagnostic work-up [ Time Frame: 4 year ] [ Designated as safety issue: No ]
- prognostic ability of the PET standard uptake value (SUV) in predicting 3-year overall survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Enrollment: | 404 |
| Study Start Date: | November 2005 |
| Study Completion Date: | April 2013 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
PET diagnostic imaging
|
Procedure: PET diagnostic imaging
PET diagnostic imaging
Other Name: Positron Emission Tomography
|
|
No Intervention: 2
No PET
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologic proof of previous colorectal adenocarcinoma (not carcinoid, squamous cell cancer, gastrointestinal stromal tumor, or lymphoma)
- Contrast-enhanced spiral CT scan of the thorax, and a tri-phasic CT scan of the abdomen and pelvis performed within 30 days (plus up to 14 days) before randomization demonstrating resectable metastasis(es) that are isolated to the liver
- Full colonoscopy performed within the preceding 18 months showing no evidence of malignancy (other than a synchronous colorectal primary expected to be removed at time of liver resection)
- Age over 18 years
Exclusion Criteria:
- Extrahepatic disease including enlarged portal lymph nodes on CT
- Prior liver resection
- Previous radiofrequency ablation of malignant liver lesion
- Systemic chemotherapy within three weeks prior to randomization
- Radiotherapy within two months prior to randomization
- Significant concurrent medical problems (e.g., uncontrolled diabetes, active cardiac disease, significant chronic obstructive pulmonary disease) making the patient unfit for surgery
- Pregnant or lactating female
- Unable to lie supine for imaging with PET
- Previously treated cancer other than non-melanocytic skin cancer or carcinoma in situ of the cervix, unless disease-free for 5 years or greater
- Patients who, at the time of the initial evaluation, have already undergone a whole body PET within 6 months prior to randomization
Contacts and Locations| Canada, Ontario | |
| St. Joseph's Healthcare | |
| Hamilton, Ontario, Canada, L8N 4A6 | |
| Hamilton Health Sciences | |
| Hamilton, Ontario, Canada, L8N 3Z5 | |
| Cancer Centre of Southeastern Ontario at Kingston General Hospital | |
| Kingston, Ontario, Canada, K7L 5P9 | |
| Grand River Regional Cancer Centre | |
| Kitchener, Ontario, Canada, N2G 1G3 | |
| London Health Sciences | |
| London, Ontario, Canada, N6A 5A5 | |
| The Ottawa Hospital Regional Cancer Centre | |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| University Health Network | |
| Toronto, Ontario, Canada, M5G 1X5 | |
| Toronto Sunnybrook Regional Cancer Centre | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| St. Joseph's Health Centre | |
| Toronto, Ontario, Canada, M6R 1B5 | |
| Study Chair: | Steven Gallinger, MD | University Health Network: Mount Sinai Hospital |
| Principal Investigator: | Mark Levine, MD | Ontario Clinical Oncology Group (OCOG) |
| Principal Investigator: | Carol-anne Moulton, MD | University Health Network: Toronto General Hospital |
More Information
No publications provided
| Responsible Party: | Ontario Clinical Oncology Group (OCOG) |
| ClinicalTrials.gov Identifier: | NCT00265356 History of Changes |
| Other Study ID Numbers: | CTA-Control-098389 |
| Study First Received: | December 12, 2005 |
| Last Updated: | May 3, 2013 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Ontario Clinical Oncology Group (OCOG):
|
Positron Emission Tomography (PET) Diagnostic Investigation Colorectal cancer Liver metastases Liver surgery |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Colorectal Neoplasms Neoplasm Metastasis Neoplasms, Second Primary Liver Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Intestinal Neoplasms |
Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Neoplastic Processes Pathologic Processes Liver Diseases |
ClinicalTrials.gov processed this record on June 17, 2013