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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cervical Cancer, Squamous Cell Carcinoma, Adenosquamous Carcinoma, Adenocarcinoma

Intervention / Treatment
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* Procedure: CT Abdomen and Pelvis scan + whole body PET-CT scan
* Procedure: CT Abdomen and Pelvis scan


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Positron Emission Tomography (PET), Diagnostic Intervention, Locally Advanced Cervical Cancer