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

January 28, 2020 updated by: Ontario Clinical Oncology Group (OCOG)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

171

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Juravinski Cancer Centre
      • London, Ontario, Canada, N6A 4L6
        • London Health Sciences Centre - London Regional Cancer Program
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Hospital Regional Cancer Centre
      • Thunder Bay, Ontario, Canada, P7B 6V4
        • Thunder Bay Regional Health Sciences Centre
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital
      • Toronto, Ontario, Canada, M4N 3M5
        • Odette Cancer Centre (Toronto-Sunnybrook)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women with newly diagnosed histologically confirmed FIGO Stage IB-IVA carcinoma of the cervix, including squamous, adenosquamous or adenocarcinoma. Women not suitable for surgery due to comorbidities (medical or other conditions) are also considered eligible.
  • Age equal to or greater than 18 years
  • Being considered for treatment with curative intent using concurrent chemotherapy and pelvic RT.

Exclusion Criteria:

  • ECOG performance status greater than 2.
  • Other cervical cancer tumour types (e.g. neuroendocrine, serous).
  • Carcinoma of the cervical stump.
  • Prior hysterectomy.
  • Patients who, at the time of the initial evaluation, have already undergone a whole body PET-CT within the last 6 months.
  • Contraindications to 18FDG PET-CT or CT of the abdomen and pelvis.
  • Inability to lie supine for imaging with PET-CT.
  • Contraindication to radiotherapy (i.e., significant Crohn's disease).
  • Contraindication to cisplatin chemotherapy (i.e., non-reversible renal failure).
  • Inadequate bone marrow function: ANC less than 1.5 X 10^9, platelets less than 100 X 10^9.
  • Inadequate renal function: Creatinine greater/equal to 150 micromol/L
  • Inadequate hepatic function: Bilirubin greater than 1.5 X ULN and SGOT and Alkaline Phosphatase greater than 3 X ULN.
  • History of another invasive malignancy within the previous 5 years with the exception of non-melanoma skin cancer.
  • Other medical conditions that may preclude chemo-radiation therapy.
  • Known pregnancy or lactating.
  • Inability to complete study or required follow-up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
CT Abdomen and Pelvis + whole body PET-CT
Procedure: CT Abdomen and Pelvis scan + whole body PET-CT scan
Pre-treatment scan
Active Comparator: 2
CT Abdomen and Pelvis
Procedure: CT Abdomen and Pelvis scan
Pre-treatment scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Event free survival (EFS) of all patients.
Time Frame: 5 years
5 years
Overall Survival (OS) of all patients.
Time Frame: 5 years
5 years
Economic and Quality of Life analyses of all patients.
Time Frame: 2 years
2 years
Standardized Uptake Value (SUV) in predicting the EFS and OS of all patients.
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ontario Clinical Oncology Group (OCOG)

Collaborators

Ontario Ministry of Health and Long Term Care

Investigators

  • Principal Investigator: Anthony Fyles, MD, Princess Margaret Hospital, Canada
  • Principal Investigator: Laurie Elit, MD, Juravinski Cancer Centre, Canada
  • Principal Investigator: Greg Pond, PhD, Ontario Clinical Oncology Group/McMaster University, Department of Oncology
  • Study Director: Mark Levine, MD, Ontario Clinical Oncology Group/McMaster University, Department of Oncology
  • Principal Investigator: Karen Gulenchyn, MD, Hamilton Health Sciences Centre
  • Principal Investigator: Mostafa Atri, MD, University Health Network, Toronto
  • Principal Investigator: Douglas Coyle, PhD, University of Ottawa Epidemiology & Community Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

August 1, 2019

Study Registration Dates

First Submitted

May 6, 2009

First Submitted That Met QC Criteria

May 7, 2009

First Posted (Estimate)

May 8, 2009

Study Record Updates

Last Update Posted (Actual)

January 29, 2020

Last Update Submitted That Met QC Criteria

January 28, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OCOG-2009-PETLACE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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