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

18 Years
Open (Enrolling)
Cervical Cancer, Squamous Cell Carcinoma, Adenosquamous Carcinoma, Adenocarcinoma

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Trial Information

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

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.

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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

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.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Laurie Elit, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Juravinski Cancer Centre, Canada


Canada: Health Canada

Study ID:




Start Date:

April 2010

Completion Date:

October 2017

Related Keywords:

  • Cervical Cancer
  • Squamous Cell Carcinoma
  • Adenosquamous Carcinoma
  • Adenocarcinoma
  • Positron Emission Tomography (PET)
  • Diagnostic Intervention
  • Locally Advanced Cervical Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Uterine Cervical Neoplasms
  • Carcinoma, Adenosquamous