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

NCT ID: NCT00895349

Last Updated: 2020-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 171 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2019-08-31

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.

Conditions

Cervical Cancer; Squamous Cell Carcinoma; Adenosquamous Carcinoma; Adenocarcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

1

CT Abdomen and Pelvis + whole body PET-CT

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

Pre-treatment scan

2

CT Abdomen and Pelvis

Group Type: ACTIVE_COMPARATOR

CT Abdomen and Pelvis scan

Intervention Type: PROCEDURE

Pre-treatment scan

Interventions

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

Pre-treatment scan

Intervention Type: PROCEDURE

CT Abdomen and Pelvis scan

Pre-treatment scan

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ontario Ministry of Health and Long Term Care

OTHER_GOV

Sponsor Role: collaborator

Ontario Clinical Oncology Group (OCOG)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurie Elit, MD

Role: PRINCIPAL_INVESTIGATOR

Juravinski Cancer Centre, Canada

Anthony Fyles, MD

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Hospital, Canada

Greg Pond, PhD

Role: PRINCIPAL_INVESTIGATOR

Ontario Clinical Oncology Group/McMaster University, Department of Oncology

Mark Levine, MD

Role: STUDY_DIRECTOR

Ontario Clinical Oncology Group/McMaster University, Department of Oncology

Karen Gulenchyn, MD

Role: PRINCIPAL_INVESTIGATOR

Hamilton Health Sciences Centre

Mostafa Atri, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Douglas Coyle, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Ottawa Epidemiology & Community Medicine

Locations

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

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 30646153 (View on PubMed)

Other Identifiers

OCOG-2009-PETLACE

Identifier Type: -

Identifier Source: org_study_id