Phase
Condition
Carcinoma
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Known or suspected non-small cell lung cancer; patients without histologically orcytologically documented non-small cell lung cancer (NSCLC) must be estimated by theirphysician to have at least 75% probability of having NSCLC; the probability ofmalignancy will be predicted on the basis of known probabilities of individualclinical characteristics using a Bayesian model
Clinical or pathologic stage I to III; patients in whom pre-surgical staging has notdefinitively establish stage IV disease are eligible
Tumor mass at least 1.5 cm in maximum diameter must be present on computed tomography (CT) scan and must be included in the planned surgical biopsy or resection
Patient must be planning to undergo a surgical staging or treatment procedure (including mediastinoscopy, wedge resection, lobectomy, or pneumonectomy) and have theclinical and physiological status appropriate for this procedure
Performance status 0-2
Bilirubin within normal limits
Creatinine within normal limits or, if elevated, a creatinine clearance of at least 60mL/min/m^2 (EF5 is primarily excreted via the kidney)
White blood cell (WBC) > 2000/mm^3
Platelets > 100,000/mm^3
Exclusion
Exclusion Criteria:
Pregnancy or breast feeding; a negative serum pregnancy test is required of any womanof childbearing potential prior to enrollment; pregnant women are excluded from thisstudy; breastfeeding should be discontinued if the mother is treated with EF5
Allergy to IV contrast dye
History of grade III or IV peripheral neuropathy as defined by the National CancerInstitute (NCI) Common Terminology Criteria (CTC)
Study Design
Study Description
Connect with a study center
Duke University Medical Center
Durham, North Carolina 27710
United StatesSite Not Available
Durham Veterans Affairs Medical Center
Durham, North Carolina 27705
United StatesSite Not Available
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