Clinical Trial: Impact of Positron Emission Tomography (PET) Imaging in Women With Locally Advanced Cervical Cancer (PET LACE Trial)

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: The Impact of Positron Emission Tomography (PET) Imaging in Women With Locally Advanced Cervical Cancer

Brief Summary:

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.


Detailed Summary:

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.


Sponsor: Ontario Clinical Oncology Group (OCOG)

Current Primary Outcome: 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 ]

Original Primary Outcome: The proportion of patients who have a change in management resulting from pre-treatment PET-CT or from CT abdomen and pelvis alone. [ Time Frame: 5 years ]

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • Event free survival (EFS) and overall survival (OS) of all patients. [ Time Frame: 5 years ]
  • Disease specific and global QoL of all patients. [ Time Frame: 5 years ]
  • Health economic analysis of the strategy of pre-treatment imaging with PET-CT compared to CT of the abdomen and pelvis alone. [ Time Frame: 5 years ]
  • The prognostic ability of the PET standard uptake value (SUV)in predicting the EFS and OS in patients with cervical cancer. [ Time Frame: 5 years ]


Information By: Ontario Clinical Oncology Group (OCOG)

Dates:
Date Received: May 6, 2009
Date Started: April 2010
Date Completion: October 2019
Last Updated: September 12, 2016
Last Verified: September 2015