Phase I/II study of photodynamic therapy (PDT) using talaporfin sodium and diode laser for local failure after chemoradiotherapy (CRT) or radiotherapy (RT) for patients with esophageal cancer - Phase I/II study of PDT using talaporfin sodium and diode laser after CRT for esophageal cancer

Kyoto University0 个研究点目标入组 28 人开始时间: 2010年10月1日最近更新: 2023年10月17日

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•Phase I 1) severe complication as follows; uncontrollable hypertension, uncontrollable diabetes mellitus, severe liver cirrhosis, severe cardiovascular disease (myocardial infarction, angina pectoris, congestive heart failure) 2) systemic infection 3) inability to keep sun shade 4) additional PDT just after salvage EMR for local failure after CRT or RT 5) baseline T4 to Aorta 6) known porphyria 7) photosensitive disorder 8) prior PDT using talaporfin sodium, prior PDT using porfimer sodium within 3 months. 9) woman during pregnancy or breast-feeding, patient who refuse to prevent pregnancy 10) patient judged as inadequate to entry by each investigator Phase II 1) other active malignancies except for early gastrointestinal cancer curable with endoscopic treatment 2) severe complication as follows; uncontrollable hypertension, uncontrollable diabetes mellitus, severe liver cirrhosis, severe cardiovascular disease (myocardial infarction, angina pectoris, congestive heart failure) 3) systemic infection 4) inability to keep sun shade 5) additional PDT just after salvage EMR for local failure after CRT or RT 6) baseline T4 to Aorta 7) known porphyria 8) photosensitive disorder 9) prior PDT using talaporfin sodium or porfimer sodium. 10) woman during pregnancy or breast-feeding, patient who refuse to prevent pregnancy 11) patient judged as inadequate to entry by each investigator

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