Multi-institutional phase II study of photodynamic therapy using ME2906 and PNL6405EPG for patients with local failure after chemoradiotherapy for esophageal cancer
- Conditions
- Patients with local failure after chemoradiotherapy for esophageal cancer
- Registration Number
- JPRN-UMIN000009184
- Lead Sponsor
- Kyoto University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 25
Not provided
1) patients with lymph node or distant metastasis with indication for systemic chemotherapy 2) active malignancy at other organs, except for cancer which are unnecessary to be treated with systemic treatment within 6 months, or curable cancer with local treatment 3) significant cardiovascular diseases (uncontrolled hypertension, myocardial infarction, unstable angina, congestive heart failure), uncontrolled diabetes mellitus, or severe liver cirrhosis, severe renal failure 4)severe systemic infection 5) judged by investigator that inability to obey the sun shade restrictions 6) baseline lesions before CRT or RT judged to involve the aorta 7) porphyria 8) additional PDT just after salvage endoscopic mucosal resection or endoscopic submucosal dissection for local failures 9) preexisting of sun photosensitivity 10) history of treatment with PDT using porfimer sodium or talaporfin sodium 11) pregnant or nursed women, or unwillingness to use of contraception 12) Severe bleeding or shock status 13) tendency of hemorrhage 14) participating in other clinical trials or within 3 months after retirement of prior clinical trial, 15) judged by investigator that enrollment was inappropriate for the patient.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ocal complete response
- Secondary Outcome Measures
Name Time Method (1)Confirmed local complete response (2)Local-progression free survival, progression free survival, Local-time to treatment failure, overall survival (3)Lesion local-complete response (4)Lesion confirmed local-complete response