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

This study has been terminated.
(On 30-Jun-2014 as per recommendations from Steering Committee; due to low recruitment rate.)
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: July 8, 2014
Last verified: July 2014
  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 ]

Enrollment: 171
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Canada, Ontario
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
London Health Sciences Centre - London Regional Cancer Program
London, Ontario, Canada, N6A 4L6
Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada, P7B 6V4
Odette Cancer Centre (Toronto-Sunnybrook)
Toronto, Ontario, Canada, M4N 3M5
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
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: July 8, 2014
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
Genital Neoplasms, Female
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Complex and Mixed
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Neoplasms
Adenocarcinoma
Carcinoma
Carcinoma, Adenosquamous
Carcinoma, Squamous Cell
Genital Diseases, Female
Uterine Diseases

ClinicalTrials.gov processed this record on October 21, 2014