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Role of Radiology in the Pretreatment Evaluation of Invasive Cervical Cancer


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Female
Cervical Cancer

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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 CenterNew York, New York  10021
Morristown Memorial HospitalMorristown, New Jersey  07962-1956