Cervical Cancer Clinical Trial
Official title:
Evaluation of Hypoxia by EF5 (NSC#684681) Binding in Cervix Cancer
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.
OBJECTIVES:
- 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.
;
Masking: Open Label, Primary Purpose: Diagnostic
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