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| Name | Class |
|---|---|
| Ontario Ministry of Health and Long Term Care | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | CT Abdomen and Pelvis + whole body PET-CT |
|
| 2 | Active Comparator | CT Abdomen and Pelvis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT Abdomen and Pelvis scan + whole body PET-CT scan | Procedure | Pre-treatment scan |
| |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laurie Elit, MD | Juravinski Cancer Centre, Canada | Principal Investigator |
| Anthony Fyles, MD | Princess Margaret Hospital, Canada | Principal Investigator |
| Greg Pond, PhD | Ontario Clinical Oncology Group/McMaster University, Department of Oncology | Principal Investigator |
| Mark Levine, MD | Ontario Clinical Oncology Group/McMaster University, Department of Oncology | Study Director |
| Karen Gulenchyn, MD | Hamilton Health Sciences Centre | Principal Investigator |
| Mostafa Atri, MD | University Health Network, Toronto | Principal Investigator |
| Douglas Coyle, PhD | University of Ottawa Epidemiology & Community Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Juravinski Cancer Centre | Hamilton | Ontario | L8V 5C2 | Canada | ||
| London Health Sciences Centre - London Regional Cancer Program |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30646153 | Derived | 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. |
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| CT Abdomen and Pelvis scan |
| Procedure |
Pre-treatment scan |
|
| 2 years |
| Standardized Uptake Value (SUV) in predicting the EFS and OS of all patients. | 5 years |
| London |
| Ontario |
| N6A 4L6 |
| Canada |
| Ottawa Hospital Regional Cancer Centre | Ottawa | Ontario | K1H 8L6 | Canada |
| Thunder Bay Regional Health Sciences Centre | Thunder Bay | Ontario | P7B 6V4 | Canada |
| Odette Cancer Centre (Toronto-Sunnybrook) | Toronto | Ontario | M4N 3M5 | Canada |
| Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| D018196 | Carcinoma, Adenosquamous |
| D000230 | Adenocarcinoma |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |
| D018193 | Neoplasms, Complex and Mixed |
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