Impact of Positron Emission Tomography (PET) Imaging in Women With Locally Advanced Cervical Cancer (PET LACE Trial)
PET LACE
The Impact of Positron Emission Tomography (PET) Imaging in Women With Locally Advanced Cervical Cancer
1 other identifier
interventional
171
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2010
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2009
CompletedFirst Posted
Study publicly available on registry
May 8, 2009
CompletedStudy Start
First participant enrolled
April 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2019
CompletedJanuary 29, 2020
January 1, 2020
4.2 years
May 6, 2009
January 28, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
2 years
Secondary Outcomes (4)
Event free survival (EFS) of all patients.
5 years
Overall Survival (OS) of all patients.
5 years
Economic and Quality of Life analyses of all patients.
2 years
Standardized Uptake Value (SUV) in predicting the EFS and OS of all patients.
5 years
Study Arms (2)
1
EXPERIMENTALCT Abdomen and Pelvis + whole body PET-CT
2
ACTIVE COMPARATORCT Abdomen and Pelvis
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2, Canada
London Health Sciences Centre - London Regional Cancer Program
London, Ontario, N6A 4L6, Canada
Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, K1H 8L6, Canada
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, P7B 6V4, Canada
Odette Cancer Centre (Toronto-Sunnybrook)
Toronto, Ontario, M4N 3M5, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
Related Publications (1)
Elit LM, Fyles AW, Gu CS, Pond GR, D'Souza D, Samant R, Anthes M, Thomas G, Filion M, Arsenault J, Dayes I, Whelan TJ, Gulenchyn KY, Metser U, Dhamanaskar K, Levine MN. Effect of Positron Emission Tomography Imaging in Women With Locally Advanced Cervical Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2018 Sep 7;1(5):e182081. doi: 10.1001/jamanetworkopen.2018.2081.
PMID: 30646153DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2009
First Posted
May 8, 2009
Study Start
April 1, 2010
Primary Completion
June 1, 2014
Study Completion
August 1, 2019
Last Updated
January 29, 2020
Record last verified: 2020-01