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 1

Recruiting

• Conditions: Esophageal cancer

• Registration Number: JPRN-UMIN000003970
• Lead Sponsor: Kyoto University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-10-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Phase I: Dose limiting toxicity of each laser irradiation level Phase II: Complete response rate of primary site