EF5 to Detect Tumor Hypoxia in Patients With Stage IIB, Stage IIIB, or Stage IVA Cervical Cancer
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|ClinicalTrials.gov Identifier: NCT00049231|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 24, 2013
RATIONALE: Knowing the level of oxygen in tumor tissue may help predict the effectiveness of anticancer therapy. EF5 may be effective in measuring oxygen in tumor tissue and helping to predict the effectiveness of anticancer therapy.
PURPOSE: Diagnostic trial to study the effectiveness of EF5 in detecting tumor hypoxia in patients who have stage IIB, stage IIIB, or stage IVA cervical cancer.
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer||Drug: EF5 Other: immunohistochemistry staining method Procedure: biopsy||Not Applicable|
- Determine the relationship between the level of EF5 binding and pretreatment hemoglobin level, tumor size, and stage of disease in patients with stage IIB, IIIB, or IVA cervical cancer.
- Determine whether pretreatment tumor hypoxia (measured by EF5 binding) is associated with overall survival, progression-free interval, and local control in these patients.
- Determine the relationship between EF5 binding and CD-31 labeling (tumor vasculature) and Ki-67 labeling (cellular proliferation) in these patients.
OUTLINE: This is a multicenter study.
Patients receive EF5 IV over 1-2.5 hours on day 1. Tumor hypoxia is measured using immunohistochemical techniques. Biopsies are collected 1-2 days later. Blood is collected before EF5 is administered and again at the time of surgery.
Patients are followed approximately 1 month after surgery.
PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study within 3 years.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Hypoxia by EF5 (NSC#684681) Binding in Cervix Cancer|
|Study Start Date :||June 2003|
|Actual Study Completion Date :||August 2005|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00049231
|United States, Arkansas|
|Arkansas Cancer Research Center at University of Arkansas for Medical Sciences|
|Little Rock, Arkansas, United States, 72205|
|United States, Colorado|
|Colorado Gynecologic Oncology Group P.C.|
|Denver, Colorado, United States, 80218|
|United States, Missouri|
|Ellis Fischel Cancer Center at University of Missouri - Columbia|
|Columbia, Missouri, United States, 65203|
|United States, Oklahoma|
|Oklahoma University Medical Center|
|Oklahoma City, Oklahoma, United States, 73104|
|Cancer Care Associates - Midtown Tulsa|
|Tulsa, Oklahoma, United States, 74104|
|Study Chair:||Gillian M. Thomas, BSc, MD, FRCPC, FRCR (Hon)||Toronto Sunnybrook Regional Cancer Centre|