Status:
COMPLETED
Impact of Positron Emission Tomography Imaging Prior to Liver Resection for Colorectal Adenocarcinoma Metastases
Lead Sponsor:
Ontario Clinical Oncology Group (OCOG)
Collaborating Sponsors:
Ontario Ministry of Health and Long Term Care
Conditions:
Colorectal Cancer
Liver Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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-oper...
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 con...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
404 Patients enrolled
Trial Details
Trial ID
NCT00265356
Start Date
November 1 2005
End Date
April 1 2013
Last Update
October 21 2013
Active Locations (9)
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1
Hamilton Health Sciences
Hamilton, Ontario, Canada, L8N 3Z5
2
St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 4A6
3
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada, K7L 5P9
4
Grand River Regional Cancer Centre
Kitchener, Ontario, Canada, N2G 1G3