Esophageal cancer
Conditions
Interventions
PDT using talaporfin sodium and diode laser
Sponsors
Kyoto University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Phase I 1) Esophageal cancer which was treated with radiotherapy or chemoradiotherapy (>=50Gy) 2) Patients with definitive local failure who refuse salvage surgery or have physical complications that would have made surgery intolerable. 3) local failure was limited within uT2 4) local failure lesion do not involve to cervical esophagus 5)length of failure lesion is 3cm or less, and circumference is 1/2 or less of the lumen 6) Within two lesions 7) absent of distant or lymph node metastasis requiring systemic chemotherapy 8) endoscopically proved local failure, and histologically confirmation is not essential. 9) Performance status (ECOG) of 0 to 2 10) adequate organ functions 11) Written informed consent Phase II 1) Esophageal cancer which was treated with radiotherapy or chemoradiotherapy (>=50Gy) 2) Patients with histologically confirmed local failure who refuse salvage surgery or have physical complications that would have made surgery intolerable. 3) local failure lesion staging limited within uT2 4) local failure lesion do not involve to cervical esophagus 5)length of failure lesion is 3cm or less, and circumference is 1/2 or less of the lumen 6) Within two lesions 7) absent of distant or lymph node metastasis 9) Performance status (ECOG) of 0 to 2 10) adequate organ functions 11) Written informed consent
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: Dose limiting toxicity of each laser irradiation level Phase II: Complete response rate of primary site | — |
Countries
Japan
Outcome results
None listed