Impact of Positron Emission Tomography Imaging Prior to Liver Resection for Colorectal Adenocarcinoma Metastases (PETCAM)

This study has been completed.
Sponsor:
Collaborator:
Ontario Ministry of Health and Long Term Care
Information provided by (Responsible Party):
Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier:
NCT00265356
First received: December 12, 2005
Last updated: October 18, 2013
Last verified: October 2013
  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

Resource links provided by NLM:


Further study details as provided by Ontario Clinical Oncology Group (OCOG):

Primary Outcome Measures:
  • proportion of patients who have a change in management resulting from PET [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

Inclusion Criteria:

  1. Histologic proof of previous colorectal adenocarcinoma (not carcinoid, squamous cell cancer, gastrointestinal stromal tumor, or lymphoma)
  2. 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
  3. 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)
  4. Age over 18 years

Exclusion Criteria:

  1. Extrahepatic disease including enlarged portal lymph nodes on CT
  2. Prior liver resection
  3. Previous radiofrequency ablation of malignant liver lesion
  4. Systemic chemotherapy within three weeks prior to randomization
  5. Radiotherapy within two months prior to randomization
  6. Significant concurrent medical problems (e.g., uncontrolled diabetes, active cardiac disease, significant chronic obstructive pulmonary disease) making the patient unfit for surgery
  7. Pregnant or lactating female
  8. Unable to lie supine for imaging with PET
  9. Previously treated cancer other than non-melanocytic skin cancer or carcinoma in situ of the cervix, unless disease-free for 5 years or greater
  10. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00265356

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
Sponsors and Collaborators
Ontario Clinical Oncology Group (OCOG)
Ontario Ministry of Health and Long Term Care
Investigators
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 by Ontario Clinical Oncology Group (OCOG)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: October 18, 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
Colorectal Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Liver Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
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 July 10, 2014