Clinical trial NCT00004936: MRI and CT Scans to Evaluate Invasive Cervical Cancer Before Treating Patients
Official title: Role of Radiology in the Pretreatment Evaluation of Invasive Cervical Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Keywords: 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
Lead sponsor: American College of Radiology Imaging Network
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: DIAGNOSTIC

Brief summary: RATIONALE: Imaging procedures such as MRI or CT scans may improve the ability to detect cervical cancer and determine the extent of disease.

PURPOSE: Diagnostic trial to determine the effectiveness of MRI and CT scans in evaluating invasive cervical cancer before treatment of patients.

Detailed description: 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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Morristown
country: United States
facility: Morristown Memorial Hospital
state: New Jersey
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Hedvig Hricak, MD, PhD
role: STUDY_CHAIR
References:
citation: Mitchell DG, Snyder B, Coakley F, Reinhold C, Thomas G, Amendola MA, Schwartz LH, Woodward P, Pannu H, Atri M, Hricak H. Early invasive cervical cancer: MRI and CT predictors of lymphatic metastases in the ACRIN 6651/GOG 183 intergroup study. Gynecol Oncol. 2009 Jan;112(1):95-103. doi: 10.1016/j.ygyno.2008.10.005. Epub 2008 Nov 20.
citation: Hricak H, Gatsonis C, Coakley FV, Snyder B, Reinhold C, Schwartz LH, Woodward PJ, Pannu HK, Amendola M, Mitchell DG. Early invasive cervical cancer: CT and MR imaging in preoperative evaluation - ACRIN/GOG comparative study of diagnostic performance and interobserver variability. Radiology. 2007 Nov;245(2):491-8. doi: 10.1148/radiol.2452061983.
citation: Mitchell DG, Snyder B, Coakley F, Reinhold C, Thomas G, Amendola M, Schwartz LH, Woodward P, Pannu H, Hricak H. 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. 2006 Dec 20;24(36):5687-94. doi: 10.1200/JCO.2006.07.4799.
citation: Amendola MA, Hricak H, Mitchell DG, Snyder B, Chi DS, Long HJ 3rd, Fiorica JV, Gatsonis C. 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. 2005 Oct 20;23(30):7454-9. doi: 10.1200/JCO.2004.00.5397.
citation: Hricak H, Gatsonis C, Chi DS, Amendola MA, Brandt K, Schwartz LH, Koelliker S, Siegelman ES, Brown JJ, McGhee RB Jr, Iyer R, Vitellas KM, Snyder B, Long HJ 3rd, Fiorica JV, Mitchell DG; American College of Radiology Imaging Network 6651; Gynecologic Oncology Group 183. 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. 2005 Dec 20;23(36):9329-37. doi: 10.1200/JCO.2005.02.0354.