Clinical trial NCT00895349: Impact of Positron Emission Tomography (PET) Imaging in Women With Locally Advanced Cervical Cancer (PET LACE Trial)
Official title: The Impact of Positron Emission Tomography (PET) Imaging in Women With Locally Advanced Cervical Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Squamous Cell Carcinoma
Adenosquamous Carcinoma
Adenocarcinoma
Keywords: Positron Emission Tomography (PET)
Diagnostic Intervention
Locally Advanced Cervical Cancer
Lead sponsor: Ontario Clinical Oncology Group (OCOG)
Sponsor class: OTHER
Collaborators: name: Ontario Ministry of Health and Long Term Care
First posted: 2009-05-08
Enrollment: 171
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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 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 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.

Primary outcomes:
measure: 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.
timeFrame: 2 years
Secondary outcomes:
measure: Event free survival (EFS) of all patients.
timeFrame: 5 years
measure: Overall Survival (OS) of all patients.
timeFrame: 5 years
measure: Economic and Quality of Life analyses of all patients.
timeFrame: 2 years
measure: Standardized Uptake Value (SUV) in predicting the EFS and OS of all patients.
timeFrame: 5 years
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre - London Regional Cancer Program
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital Regional Cancer Centre
state: Ontario
city: Thunder Bay
country: Canada
facility: Thunder Bay Regional Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Odette Cancer Centre (Toronto-Sunnybrook)
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: Juravinski Cancer Centre, Canada
name: Laurie Elit, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Princess Margaret Hospital, Canada
name: Anthony Fyles, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ontario Clinical Oncology Group/McMaster University, Department of Oncology
name: Greg Pond, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ontario Clinical Oncology Group/McMaster University, Department of Oncology
name: Mark Levine, MD
role: STUDY_DIRECTOR
affiliation: Hamilton Health Sciences Centre
name: Karen Gulenchyn, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Health Network, Toronto
name: Mostafa Atri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Ottawa Epidemiology & Community Medicine
name: Douglas Coyle, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.