The purpose of this trial is to improve the clinical management and outcome of patients with locally advanced cervical cancer by using positron emission tomography-computed tomography (PET-CT) imaging. There is considerable debate worldwide regarding the utility of PET for staging cervical cancer. Although there are studies on the accuracy (sensitivity and specificity) of PET in cervical cancer, there are currently no prospective randomized studies on how PET information affects treatment decisions and outcomes.
Cervical cancer is the second most common cause of cancer deaths worldwide. In Canada, it is estimated that in 2009 there will be 1,300 new cases of cervical cancer and that 380 women will die of this disease. The corresponding 2009 data for Ontario is 500 new cases and 140 deaths. In Canada, cervical cancer screening with the Pap test allows for the diagnosis and curative treatment of precancerous lesions of the cervix or early cervical cancers. Symptoms of cervical cancer include vaginal bleeding and discharge. Unfortunately these are often associated with more advanced disease. The costs associated with health care are increasing. PET is an expensive imaging modality. Given that resources for health care are not unlimited, there needs to be high quality evidence of an intervention such as PET's efficacy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
171
Pre-treatment scan
Pre-treatment scan
Juravinski Cancer Centre
Hamilton, Ontario, Canada
London Health Sciences Centre - London Regional Cancer Program
London, Ontario, Canada
Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, Canada
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada
Odette Cancer Centre (Toronto-Sunnybrook)
Toronto, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Treatment delivered between patients having whole body 18FDG PET-CT in addition to CT of the abdomen and pelvis versus patients having a CT of the abdomen and pelvis alone.
Time frame: 2 years
Event free survival (EFS) of all patients.
Time frame: 5 years
Overall Survival (OS) of all patients.
Time frame: 5 years
Economic and Quality of Life analyses of all patients.
Time frame: 2 years
Standardized Uptake Value (SUV) in predicting the EFS and OS of all patients.
Time frame: 5 years
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