Patients with local failure after chemoradiotherapy for esophageal cancer
Conditions
Interventions
One hundred milligrams of talaporfin sodium are dissolved in 4 mL of saline, and a 40 mg/m2 dose is slowly injected intravenously. Four to 6 hours after administration of talaporfin sodium, the local
Sponsors
Kyoto University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Local failure after CRT or RT(>= 50 Gy) for esophageal cancer 2) The duration from the last day of prior treatment was one week or more. Any prior treatment are permitted, except for PDT using talaporfin sodium 3) With local failure lesions which are histologically proven carcinoma by biopsy specimen, and patients do not hope to treat with salvage esophagectomy or lack of tolerability for salvage esophagectomy 4) local failure lesions which are judged as it is impossible to achieve curative resection with salvage EMR or ESD 5) local failed lesions that were not involved in the cervical esophagus 6) local failed lesions limited within the muscularis propria (T2) 7) longitudinal lesion length of shorter than 3 cm and less than one half the circumference of the lumen 8) no more than 2 failure lesions; 9) age ; 20, 10) Eastern Cooperative Oncology Group performance status; 2; 11) adequate bone marrow function (white blood cell count ;2000/mm3 , hemoglobin >8.0 g/dL, platelet count ;75,000/mm3), and liver function (serum total bilirubin level ; 3.0 mg/dL, both alanine aminotransferase and aspartate aminotransferase ; 100 IU/L) 12) provision of written informed consent.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local complete response | — |
Secondary
| Measure | Time frame |
|---|---|
| (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 | — |
Countries
Japan
Contacts
Public ContactHiroi Kasai
Kyoto University Hospital Institute for Advancement of Clinical and Translational Science
Outcome results
None listed