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In addition to the cases described below, 17 patients were brought to our attention as interested and potentially eligible but ultimately were not formally evaluated nor enrolled because their clinical condition deteriorated, they opted to participate in another clinical trial, decided that participation would be too time consuming, or for other reasons.
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Patients without measurable disease and with a positive resection margin after radical surgery (tumor within 1 mm of the resection margin) were also eligible owing to their poor prognosis; these patients were evaluated for survival only.
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