NCT01016002Unknown2 期
A Phase II, Open-label, Single-arm Study of Photodynamic Laser Therapy Using Foscan for Non-curatively-resectable Bile Duct Carcinoma
University of Salzburg2 个研究点 分布在 2 个国家目标入组 35 人开始时间: 2006年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Rate of local response and depth of tumoricidal tissue penetration of Foscan-PDT
研究概览
简要总结
The purpose of this study is to assess efficacy and safety of Foscan (temoporfin) photodynamic therapy in the treatment of locally advanced perihilar bile duct carcinoma without distant metastases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •bile duct carcinoma proven by histology in advanced or non-operable stage or tumor extension:
- •Bismuth type III or IV ( not resectable with R0-margins )
- •Bismuth type I or II, if resective surgery is contraindicated for old age or poor surgical risk of patient
- •sufficient general condition to undergo PDT (Karnofsky status > 30%)
- •age > 19 years
- •access to common bile duct (either via endoscopy after sphincterotomy or percutaneously after transhepatic drainage),
- •informed written consent
排除标准
- •porphyria or other diseases exacerbated by light
- •known intolerance or allergies to porphyrin derivatives
- •a planned surgical procedure within the next 30 days
- •coexisting ophthalmic disease likely to require slit lamp examination within the next 30 days
- •impaired kidney or liver function (creatinine > 2.5x elevated, INR > 2.2 on vitamin K),
- •leukopenia ( WBC < 2000/cmm ) or thrombopenia ( < 50000/cmm ),
- •cytotoxic chemotherapy within the past 4 weeks.
- •pregnancy ( and safe contraception for 6 months after PDT )
- •accompanying/complicating disease with very poor prognosis (expected survival < 6 weeks),
- •proven advanced peritoneal carcinomatosis ( PET scan imaging, ascites positive for tumor cells)
研究组 & 干预措施
Intervention
Experimental
干预措施: Temoporfin (Drug)
结局指标
主要结局
Rate of local response and depth of tumoricidal tissue penetration of Foscan-PDT
时间窗: post treatment
次要结局
- Progression-free survival time, overall survival time(Before first intervention and at months 1, 3, 6, 9, 12, 18 and 24 after intervention)
- Toxicity using WHO criteria and criteria for local toxicity in the biliary system(Before first intervention and at months 1, 3, 6, 9, 12, 18 and 24 after intervention)
研究者
研究点 (2)
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