Role of Radiology in the Pretreatment Evaluation of Invasive Cervical Cancer
N/A
N/A
Female
Cervical Cancer
Trial Information
Role of Radiology in the Pretreatment Evaluation of Invasive Cervical Cancer
OBJECTIVES:
- Compare the diagnostic performance of magnetic resonance imaging (MRI), computed
tomography (CT), and clinical FIGO staging in patients with invasive cervical cancer.
- Compare the accuracy of MRI, CT, and clinical FIGO staging in the evaluation of
morphologic tumor prognostic factors in FIGO stage IB1 and stage IB2 and greater in
these patients.
- Examine the value of imaging assessment of tumor prognostic factors (alone or in
combination) as predictors of recurrence within 2 years of surgery in these patients.
- Evaluate the quality of life in the 12-month period after staging and treatment to
potentially change staging accuracy.
OUTLINE: This is a multicenter study.
Patients undergo a computed tomography scan with iodinated contrast dye followed by a
magnetic resonance imaging scan with or without contrast comprising gadopentetate
dimeglumine or vice versa.
Within 6 weeks of first protocol imaging study, patients undergo one of the following
surgeries:
- Laparoscopic, transabdominal, or transvaginal hysterectomy
- Extrafascial total abdominal hysterectomy
- Trachelectomy Quality of life is assessed at 1 and 12 months.
Patients are followed every 3 months for 1 year and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 465 patients will be accrued for this study within 18 months.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed invasive cervical cancer, including invasive squamous cell
carcinoma, adenocarcinoma, or adenosquamous carcinoma
- FIGO stage IB1 with clinically visible gross lesion OR
- FIGO stage IB2 or greater
- Scheduled for one of the following surgeries at a participating Gynecological
Oncology Group center:
- Laparoscopic, transabdominal, or transvaginal hysterectomy
- Extrafascial total abdominal hysterectomy
- Trachelectomy
- Not scheduled for a loop electrosurgical excision procedure or a cone biopsy only
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Cardiovascular:
- No cardiac pacemakers
Pulmonary:
- No asthma
Other:
- Not pregnant
- No contraindication to computed tomography (CT) (e.g., history of allergy to CT
contrast medium)
- No contraindication to magnetic resonance imaging (e.g., intracranial vascular clip)
- No nonmalignant general medical or psychiatric condition that would preclude consent
or surgery
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy for invasive cervical cancer
Surgery:
- See Disease Characteristics
- No prior surgery for invasive cervical cancer
Other:
- No prior medical treatment for invasive cervical cancer
Type of Study:
Interventional
Study Design:
Primary Purpose: Diagnostic
Principal Investigator
Hedvig Hricak, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000067622
NCT ID:
NCT00004936
Start Date:
April 2000
Completion Date:
October 2002
Related Keywords:
- Cervical Cancer
- stage III cervical cancer
- stage IB cervical cancer
- stage IIB cervical cancer
- stage IVB cervical cancer
- stage IIA cervical cancer
- stage IVA cervical cancer
- cervical squamous cell carcinoma
- cervical adenocarcinoma
- cervical adenosquamous cell carcinoma
- Uterine Cervical Neoplasms
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| Morristown Memorial Hospital | Morristown, New Jersey 07962-1956 |
