Stage III Adult Soft Tissue Sarcoma Clinical Trial
Official title:
Does Hypoxia Predict Radiation/Surgical Tumor Response/A Correlative Trial of EF5, an Agent for the Detection of Tumor Hypoxia
This laboratory study is using EF5 to evaluate tumor hypoxia in patients with high-grade soft tissue sarcoma or mouth cancer. Using the drug EF5 to measure the oxygen level in tumor cells may help in planning cancer treatment
PRIMARY OBJECTIVES:
I. Determine biologically-relevant hypoxia by imaging and cellular analysis of EF5 binding
in patients with high-grade soft tissue sarcoma of the trunk or extremity or squamous cell
carcinoma of the oral cavity.
II. Determine the spatial relationships between EF5 binding and various tumor tissue
markers, pathological processes, and serum plasminogen activator inhibitor-1 in these
patients.
III. Correlate EF5 binding with Eppendorf electrode measurement and patient-related factors
in these patients.
IV. Determine the adjusted and unadjusted associations between clinical outcome and optimal
measures of EF5 binding, patient/tumor characteristics, and biological markers in these
patients.
OUTLINE:
Approximately 24-48 hours prior to surgical resection or biopsy, patients receive EF5 IV
over no more than 2½ hours. Tissue samples are analyzed by immunohistochemistry for EF5
binding. Blood samples are analyzed for genetic markers and cytokines associated with
hypoxia and EF5 concentration.
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Intervention Model: Single Group Assignment, Masking: Open Label
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