Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

MRI and CT Scans to Evaluate Invasive Cervical Cancer Before Treating Patients

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Diagnostic Completed Not specified NCI ACRIN-6651 NCT00004936, ACRIN-6651, GOG-183

Objectives

1. Compare the diagnostic performance of magnetic resonance imaging (MRI), computed tomography (CT), and clinical FIGO staging in patients with invasive cervical cancer.
2. 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.
3. 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.
4. Evaluate the quality of life in the 12-month period after staging and treatment to potentially change staging accuracy.

Entry 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

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

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

Expected Enrollment

A total of 465 patients will be accrued for this study within 18 months.

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.

Hricak H, Gatsonis C, Coakley FV, et al.: Early invasive cervical cancer: CT and MR imaging in preoperative evaluation - ACRIN/GOG comparative study of diagnostic performance and interobserver variability. Radiology 245 (2): 491-8, 2007.[PUBMED Abstract]

Mitchell DG, Snyder B, Coakley F, et al.: Early invasive cervical cancer: tumor delineation by magnetic resonance imaging, computed tomography, and clinical examination, verified by pathologic results, in the ACRIN 6651/GOG 183 Intergroup Study. J Clin Oncol 24 (36): 5687-94, 2006.[PUBMED Abstract]

Amendola MA, Hricak H, Mitchell DG, et al.: Utilization of diagnostic studies in the pretreatment evaluation of invasive cervical cancer in the United States: results of intergroup protocol ACRIN 6651/GOG 183. J Clin Oncol 23 (30): 7454-9, 2005.[PUBMED Abstract]

Hricak H, Gatsonis C, Chi DS, et al.: Role of imaging in pretreatment evaluation of early invasive cervical cancer: results of the intergroup study American College of Radiology Imaging Network 6651-Gynecologic Oncology Group 183. J Clin Oncol 23 (36): 9329-37, 2005.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

American College of Radiology Imaging Network

Hedvig Hricak, MD, PhD, Protocol chair		Ph: 212-639-7284; 800-525-2225

Registry Information
Official Title		Role of Radiology in the Pretreatment Evaluation of Invasive Cervical Cancer
Trial Start Date		2000-04-17
Registered in ClinicalTrials.gov		NCT00004936
Date Submitted to PDQ		2000-01-13
Information Last Verified		2003-04-01
NCI Grant/Contract Number		CA080098