跳至主要内容
临床试验/NCT01795274
NCT01795274撤回不适用

Phase I Study Evaluating the Treatment of Patients With Locally Advanced Pancreatic Cancer With Carbon Ion Radiotherapy: The PHOENIX-01 Trial

University Hospital Heidelberg2 个研究点 分布在 1 个国家开始时间: 2013年2月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Acute toxicity of carbon ion radiotherapy observed within 3 months of study treatment

研究概览

简要总结

The physical and biological properties of the carbon ion beam promise to improve the therapeutic ratio in patients with pancreatic cancer: Due to the inverted dose profile dose deposition in the entry channel of the beam leads to sparing of normal tissue; the Bragg peak can be directed into the defined target volume, and the sharp dose fall-off thereafter again spares normal tissue behind the target volume. The higher RBE of carbon ions, which has been shown also for pancreatic cancer cell lines in the preclinical setting, is likely to contribute to an increase in local control, and perhaps in OS. Early data from Japanese centers have shown convincing results. The PHOENIX-01 trial is the first trial to evaluate actively delivered carbon ion beams in patients with locally advanced pancreatic cancer within a dose-escalation strategy.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Carbon Ion Radiotherapy

Experimental

Step 1 14 x 3 Gy E 42 Gy E Step 2: 15 x 3 Gy E 45 Gy E Step 3: 16 x 3 Gy E 49 Gy E Step 4: 17 x 3 Gy E 51 Gy E Step 5: 18 x 3 Gy E 54 Gy E

干预措施: Carbon Ion Radiotherapy (Radiation)

结局指标

主要结局

Acute toxicity of carbon ion radiotherapy observed within 3 months of study treatment

时间窗: 3 months

Acute toxicity of carbon ion radiotherapy observed within 3 months of study treatment

次要结局

  • imaging response(2 years)
  • progression-free survival(2 years)
  • overall survival(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Juergen Debus

Prof. Dr. Dr. Jürgen Debus

University Hospital Heidelberg

研究点 (2)

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