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

Not Applicable

Completed

• Conditions: Adenocarcinoma; Adenosquamous Carcinoma; Cervical Cancer; Squamous Cell Carcinoma
• Interventions: Procedure: CT Abdomen and Pelvis scan; Procedure: CT Abdomen and Pelvis scan + whole body PET-CT scan

• Registration Number: NCT00895349
• Lead Sponsor: Ontario Clinical Oncology Group (OCOG)

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.

Study Timeline

• Study First Submitted: 2009-05-06
• Study First Submitted QC: 2009-05-07
• Study First Posted: 2009-05-08
• Study Start: 2010-04
• Primary Completion: 2014-06
• Study Completion: 2019-08
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-28
• Last Update Posted: 2020-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 171

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	CT Abdomen and Pelvis scan	CT Abdomen and Pelvis
1	CT Abdomen and Pelvis scan + whole body PET-CT scan	CT Abdomen and Pelvis + whole body PET-CT

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Event free survival (EFS) 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
Overall Survival (OS) of all patients.	5 years

Trial Locations

Locations (6)

Juravinski Cancer Centre; 🇨🇦 Hamilton, Ontario, Canada

London Health Sciences Centre - London Regional Cancer Program; 🇨🇦 London, Ontario, Canada

Ottawa Hospital Regional Cancer Centre; 🇨🇦 Ottawa, Ontario, Canada

Thunder Bay Regional Health Sciences Centre; 🇨🇦 Thunder Bay, Ontario, Canada

Odette Cancer Centre (Toronto-Sunnybrook); 🇨🇦 Toronto, Ontario, Canada

Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada