Status:
COMPLETED
Impact of Positron Emission Tomography (PET) Imaging in Women With Locally Advanced Cervical Cancer (PET LACE Trial)
Lead Sponsor:
Ontario Clinical Oncology Group (OCOG)
Collaborating Sponsors:
Ontario Ministry of Health and Long Term Care
Conditions:
Cervical Cancer
Squamous Cell Carcinoma
Eligibility:
FEMALE
18+ years
Phase:
NA
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2019
Estimated Enrollment :
171 Patients enrolled
Trial Details
Trial ID
NCT00895349
Start Date
April 1 2010
End Date
August 1 2019
Last Update
January 29 2020
Active Locations (6)
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1
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
2
London Health Sciences Centre - London Regional Cancer Program
London, Ontario, Canada, N6A 4L6
3
Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6
4
Thunder Bay Regional Health Sciences Centre
Thunder Bay, Ontario, Canada, P7B 6V4