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

This study is currently recruiting participants.
Verified August 2013 by Ontario Clinical Oncology Group (OCOG)
Sponsor:
Collaborator:
Ontario Ministry of Health and Long Term Care
Information provided by (Responsible Party):
Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier:
NCT00895349
First received: May 6, 2009
Last updated: August 26, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Cervical Cancer
Squamous Cell Carcinoma
Adenosquamous Carcinoma
Adenocarcinoma
Procedure: CT Abdomen and Pelvis scan + whole body PET-CT scan
Procedure: CT Abdomen and Pelvis scan

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 in Women With Locally Advanced Cervical Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Event free survival (EFS) of all patients. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Overall Survival (OS) of all patients. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Economic and Quality of Life analyses of all patients. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Standardized Uptake Value (SUV) in predicting the EFS and OS of all patients. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 288
Study Start Date: April 2010
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00895349

Contacts
Contact: Marc Filion, MSc, CCRP 905-527-2299 ext 42611 filion@mcmaster.ca

Locations
Canada, Ontario
Juravinski Cancer Centre Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Shirley-Ann Hahn, RN    (905) 387-9711      
Principal Investigator: Laurie Elit, MD         
London Health Sciences Centre - London Regional Cancer Program Recruiting
London, Ontario, Canada, N6A 4L6
Contact: Kes Sebborn, CCRP    519-685-8618    Kes.Sebborn@lhsc.on.ca   
Principal Investigator: David D'Souza, MD         
Ottawa Hospital Regional Cancer Centre Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: Doreen Whelan, BScN, RN    613-737-7700 ext 70314    dwhelan@toh.on.ca   
Principal Investigator: Rajiv Samant, MD         
Thunder Bay Regional Health Sciences Centre Recruiting
Thunder Bay, Ontario, Canada, P7B 6V4
Contact: Lisa Miedema, R.N., B.Sc.N., B.Sc.    807-684-7234    miedemal@tbh.net   
Principal Investigator: Margaret Anthes, MD         
Odette Cancer Centre (Toronto-Sunnybrook) Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Jessica Marer    416-480-5000 ext 7387    jessica.marer@sunnybrook.ca   
Principal Investigator: Lisa Barbera, MD         
Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Jasmin Bico-Ponce, BSc, CCRP    416-946-4501 ext 5062    bico-ponce@rmp.uhn.on.ca   
Principal Investigator: Anthony Fyles, MD         
Sponsors and Collaborators
Ontario Clinical Oncology Group (OCOG)
Ontario Ministry of Health and Long Term Care
Investigators
Principal Investigator: Laurie Elit, MD Juravinski Cancer Centre, Canada
Principal Investigator: Anthony Fyles, MD Princess Margaret Hospital, 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
  More Information

No publications provided

Responsible Party: Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier: NCT00895349     History of Changes
Other Study ID Numbers: OCOG-2009-PETLACE
Study First Received: May 6, 2009
Last Updated: August 26, 2013
Health Authority: Canada: Health Canada

Keywords provided by Ontario Clinical Oncology Group (OCOG):
Positron Emission Tomography (PET)
Diagnostic Intervention
Locally Advanced Cervical Cancer

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Neoplasms, Complex and Mixed
Adenocarcinoma
Carcinoma
Carcinoma, Squamous Cell
Carcinoma, Adenosquamous
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on April 17, 2014