Sequential Combination of Chemotherapy With Gemcitabine/Oxaliplatin and Photodynamic Therapy in Advanced Cholangiocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Progression free survival 6 months after study start
研究概览
简要总结
In patients with cholangiocarcinoma therapeutic effects have been reported for Gemcitabine/Oxaliplatin. Furthermore, photodynamic therapy (PDT) has significantly improved patients survival in two randomised trials. PDT induces tumor necrosis only in an area of few millimetres, while tumor parts which are located beyond this area remain untreated. An additive effect could result from PDT as a local therapy in combination with systemic chemotherapy.
详细描述
Patients entered in the study receive a sequential therapy consisted of photodynamic therapy followed by systemic chemotherapy (Gemcitabine/Oxaliplatin) 4 weeks later. Systemic chemotherapy every 2 weeks is scheduled 9 times in each cycle. Thereafter, another cycle of PDT followed by chemotherapy is intended.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologic/cytologic verified cholangiocarcinoma or cholangiocarcinoma-typical findings in >= 2 diagnostic methods
- •Bile duct stenoses which are technically successful treated with biliary drainage
- •Irresectability/inoperability
- •Karnofsky-Index >= 60%
- •Age >= 18
- •Written consent
- •Before chemotherapy:
- •Bilirubin <= 5 mg/dl
- •GOT/GPT < 5x upper standard
- •Creatinine < 2x upper standard
- •Thrombocytes > 100 G/l
- •Neutrophils > 2,00 G/l
- •Haemoglobin > 9 g/dl
- •No occurence of complications during endoscopic procedures (abscess, bilioma, cholecystitis, cholangitis, pancreatitis, biliary leakage)
排除标准
- •Implantation of a metal stent in the bile duct
- •Previous PDT or chemotherapy
- •Neoplasia
- •Porphyria
- •Pregnant or breastfeeding women
- •Women of childbearing age and potent men who are not using highly effective contraceptives
研究组 & 干预措施
1
Treatment by combination of photodynamic therapy and chemotherapy
干预措施: Gemcitabine, Oxaliplatin, Photodynamic therapy (Photosan®) (Drug)
结局指标
主要结局
Progression free survival 6 months after study start
时间窗: 6 months after study start
次要结局
- Progression free survival 12 months after study start Progression free interval Overall survival Life quality(Until 12 months after study start)