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

Primary Purpose

Cervical Cancer, Squamous Cell Carcinoma, Adenosquamous Carcinoma

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

CT Abdomen and Pelvis scan + whole body PET-CT scan

CT Abdomen and Pelvis scan

About this trial

This is an interventional diagnostic trial for Cervical Cancer focused on measuring Positron Emission Tomography (PET), Diagnostic Intervention, Locally Advanced Cervical Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Juravinski Cancer Centre
London Health Sciences Centre - London Regional Cancer Program
Ottawa Hospital Regional Cancer Centre
Thunder Bay Regional Health Sciences Centre
Odette Cancer Centre (Toronto-Sunnybrook)
Princess Margaret Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

CT Abdomen and Pelvis + whole body PET-CT

CT Abdomen and Pelvis

Outcomes

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.

Secondary Outcome Measures

Event free survival (EFS) of all patients.

Overall Survival (OS) of all patients.

Economic and Quality of Life analyses of all patients.

Standardized Uptake Value (SUV) in predicting the EFS and OS of all patients.

Full Information

NCT ID

NCT00895349

First Posted

May 6, 2009

Last Updated

January 28, 2020

Sponsor

Ontario Clinical Oncology Group (OCOG)

Collaborators

Ontario Ministry of Health and Long Term Care

1. Study Identification

Unique Protocol Identification Number

NCT00895349

Brief Title

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

Acronym

PET LACE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

April 2010 (undefined)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

August 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ontario Clinical Oncology Group (OCOG)

Collaborators

Ontario Ministry of Health and Long Term Care

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cervical Cancer, Squamous Cell Carcinoma, Adenosquamous Carcinoma, Adenocarcinoma

Keywords

Positron Emission Tomography (PET), Diagnostic Intervention, Locally Advanced Cervical Cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

171 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

CT Abdomen and Pelvis + whole body PET-CT

Arm Title

Arm Type

Active Comparator

Arm Description

CT Abdomen and Pelvis

Intervention Type

Procedure

Intervention Name(s)

CT Abdomen and Pelvis scan + whole body PET-CT scan

Intervention Description

Pre-treatment scan

Intervention Type

Procedure

Intervention Name(s)

CT Abdomen and Pelvis scan

Intervention Description

Pre-treatment scan

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Event free survival (EFS) of all patients.

Time Frame

5 years

Title

Overall Survival (OS) of all patients.

Time Frame

5 years

Title

Economic and Quality of Life analyses of all patients.

Time Frame

2 years

Title

Standardized Uptake Value (SUV) in predicting the EFS and OS of all patients.

Time Frame

5 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials: