Trial record 16 of 3225 for:
Cervical Cancer: Clinical Trials
Impact of Positron Emission Tomography (PET) Imaging in Women With Locally Advanced Cervical Cancer (PET LACE Trial)
This study is currently recruiting participants.
Verified July 2012 by Ontario Clinical Oncology Group (OCOG)
Sponsor:
Ontario Clinical Oncology Group (OCOG)
Collaborator:
Ontario Ministry of Health and Long Term Care
Information provided by (Responsible Party):
Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier:
NCT00895349
First received: May 6, 2009
Last updated: November 27, 2012
Last verified: July 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cervical Cancer Squamous Cell Carcinoma Adenosquamous Carcinoma Adenocarcinoma |
Procedure: CT Abdomen and Pelvis scan + whole body PET-CT scan Procedure: CT Abdomen and Pelvis scan |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | The Impact of Positron Emission Tomography (PET) Imaging in Women With Locally Advanced Cervical Cancer |
Resource links provided by NLM:
Further study details as provided by Ontario Clinical Oncology Group (OCOG):
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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Event free survival (EFS) of all patients. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Overall Survival (OS) of all patients. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Economic and Quality of Life analyses of all patients. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Standardized Uptake Value (SUV) in predicting the EFS and OS of all patients. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 288 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | October 2017 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
CT Abdomen and Pelvis + whole body PET-CT
|
Procedure: CT Abdomen and Pelvis scan + whole body PET-CT scan
Pre-treatment scan
|
|
Active Comparator: 2
CT Abdomen and Pelvis
|
Procedure: CT Abdomen and Pelvis scan
Pre-treatment scan
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00895349
Contacts
| Contact: Marc Filion, MSc, CCRP | 905-527-2299 ext 42611 | filion@mcmaster.ca |
Locations
| Canada, Ontario | |
| Juravinski Cancer Centre | Recruiting |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| Contact: Shirley-Ann Hahn, RN (905) 387-9711 | |
| Principal Investigator: Laurie Elit, MD | |
| London Health Sciences Centre - London Regional Cancer Program | Recruiting |
| London, Ontario, Canada, N6A 4L6 | |
| Contact: Kes Sebborn, CCRP 519-685-8618 Kes.Sebborn@lhsc.on.ca | |
| Principal Investigator: David D'Souza, MD | |
| Ottawa Hospital Regional Cancer Centre | Recruiting |
| Ottawa, Ontario, Canada, K1H 8L6 | |
| Contact: Doreen Whelan, BScN, RN 613-737-7700 ext 70314 dwhelan@toh.on.ca | |
| Principal Investigator: Rajiv Samant, MD | |
| Thunder Bay Regional Health Sciences Centre | Recruiting |
| Thunder Bay, Ontario, Canada, P7B 6V4 | |
| Contact: Lisa Miedema, R.N., B.Sc.N., B.Sc. 807-684-7234 miedemal@tbh.net | |
| Principal Investigator: Margaret Anthes, MD | |
| Odette Cancer Centre (Toronto-Sunnybrook) | Recruiting |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Contact: Jessica Marer 416-480-5000 ext 7387 jessica.marer@sunnybrook.ca | |
| Principal Investigator: Lisa Barbera, MD | |
| Princess Margaret Hospital | Recruiting |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Contact: Jasmin Bico-Ponce, BSc, CCRP 416-946-4501 ext 5062 bico-ponce@rmp.uhn.on.ca | |
| Principal Investigator: Anthony Fyles, MD | |
Sponsors and Collaborators
Ontario Clinical Oncology Group (OCOG)
Ontario Ministry of Health and Long Term Care
Investigators
| Principal Investigator: | 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 |
| Study Director: | Mark Levine, MD | Ontario Clinical Oncology Group/McMaster University, Department of Oncology |
| Principal Investigator: | 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 |
More Information
No publications provided
| Responsible Party: | Ontario Clinical Oncology Group (OCOG) |
| ClinicalTrials.gov Identifier: | NCT00895349 History of Changes |
| Other Study ID Numbers: | OCOG-2009-PETLACE |
| Study First Received: | May 6, 2009 |
| Last Updated: | November 27, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Ontario Clinical Oncology Group (OCOG):
|
Positron Emission Tomography (PET) Diagnostic Intervention Locally Advanced Cervical Cancer |
Additional relevant MeSH terms:
|
Uterine Cervical Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Neoplasms, Squamous Cell Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site |
Uterine Cervical Diseases Neoplasms, Complex and Mixed Adenocarcinoma Adenocarcinoma, Mucinous Carcinoma Carcinoma, Squamous Cell Carcinoma, Adenosquamous Uterine Diseases Genital Diseases, Female |
ClinicalTrials.gov processed this record on June 17, 2013