Cervical CancerPET LACENCT00895349

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

A study testing CT Abdomen and Pelvis scan + whole body PET-CT scan and CT Abdomen and Pelvis scan in people with Cervical Cancer and Squamous Cell Carcinoma, run by Ontario Clinical Oncology Group (OCOG) at 6 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Cervical Cancer, Squamous Cell Carcinoma, Adenosquamous Carcinoma
What is being tested?: CT Abdomen and Pelvis scan + whole body PET-CT scan and CT Abdomen and Pelvis scan
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 171 participants
Where: 6 sitesCanada
Study dates: Apr 2010to Aug 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 16Show fewer

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.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

Canada6 sites

Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
London Health Sciences Centre - London Regional Cancer Program
London, Ontario, N6A 4L6
Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, K1H 8L6
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, P7B 6V4
Odette Cancer Centre (Toronto-Sunnybrook)
Toronto, Ontario, M4N 3M5
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

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

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.

Read the 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
Being tested: CT Abdomen and Pelvis scan + whole body PET-CT scan, CT Abdomen and Pelvis scan
Keywords: Positron Emission Tomography (PET), Diagnostic Intervention, Locally Advanced Cervical Cancer
Medical subject headings: Uterine Cervical Neoplasms, Carcinoma, Squamous Cell, Carcinoma, Adenosquamous, Adenocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CT Abdomen and Pelvis scan + whole body PET-CT scanProcedure or surgery
Pre-treatment scan
CT Abdomen and Pelvis scanProcedure or surgery
Pre-treatment scan

Study groups in NCT00895349
Study group	Role	What they receive
1	Experimental	CT Abdomen and Pelvis + whole body PET-CT Receives: Procedure: CT Abdomen and Pelvis scan + whole body PET-CT scan
2	Active comparator	CT Abdomen and Pelvis Receives: Procedure: CT Abdomen and Pelvis scan

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 2 years

Secondary outcomes (4)

Event free survival (EFS) of all patients.
Measured: 5 years
Overall Survival (OS) of all patients.
Measured: 5 years
Economic and Quality of Life analyses of all patients.
Measured: 2 years
Standardized Uptake Value (SUV) in predicting the EFS and OS of all patients.
Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2010Aug 2019

First posted8 May 2009 (estimated)
Study startApr 2010
Primary completionJun 2014
Study completionAug 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Cervical CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 171 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00895349
Sponsor's protocol ID: OCOG-2009-PETLACE
Acronym: PET LACE
Status last verified: Jan 2020
First submitted: 6 May 2009
Last updated: 29 Jan 2020
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 30646153

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
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RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
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RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)

All Cervical Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Impact of Positron Emission Tomography (PET) Imaging in Women With Locally Advanced Cervical Cancer
ClinicalTrials.gov ID: NCT00895349
Acronym / sponsor ID: PET LACE / OCOG-2009-PETLACE
Conditions: Cervical Cancer, Squamous Cell Carcinoma, Adenosquamous Carcinoma, Adenocarcinoma
Keywords: Positron Emission Tomography (PET), Diagnostic Intervention, Locally Advanced Cervical Cancer
Study type: Interventional
Recruitment status: Completed
Enrolment: 171 participants (actual)
Lead sponsor: Ontario Clinical Oncology Group (OCOG)University, hospital or other
Collaborators: Ontario Ministry of Health and Long Term Care
Study start: Apr 2010
Primary completion: Jun 2014 (actual)
Study completion: Aug 2019 (actual)
First posted: 8 May 2009 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Procedure: CT Abdomen and Pelvis scan + whole body PET-CT scanCT Abdomen and Pelvis + whole body PET-CT
2	Active comparator	Procedure: CT Abdomen and Pelvis scanCT Abdomen and Pelvis

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (16 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CT Abdomen and Pelvis scan + whole body PET-CT scanPre-treatment scan	Procedure or surgery	1
CT Abdomen and Pelvis scanPre-treatment scan	Procedure or surgery	2

Primary outcome

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

4 secondary outcomes

Event free survival (EFS) of all patients.
Time frame: 5 years
Overall Survival (OS) of all patients.
Time frame: 5 years
Economic and Quality of Life analyses of all patients.
Time frame: 2 years
Standardized Uptake Value (SUV) in predicting the EFS and OS of all patients.
Time frame: 5 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
Derived from this study: PubMed 30646153Elit 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.

Related trials for Cervical Cancer

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial
Head & Neck Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Laurie Elit, MD principal investigator

Juravinski Cancer Centre, Canada

Anthony Fyles, MD principal investigator

Princess Margaret Hospital, Canada

Greg Pond, PhD principal investigator

Ontario Clinical Oncology Group/McMaster University, Department of Oncology

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00895349, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2020.