Phase I Study Evaluating the Treatment of Patients With Locally Advanced Pancreatic Cancer With Carbon Ion Radiotherapy: The PHOENIX-01 Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 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
- 否
入选标准
- •Patients meeting all of the following criteria will be considered for admission to the trial:
- •histologically confirmed locally advanced pancreatic cancer or imaging defined pancreatic cancer combined with elevated CA-19-9
- •macroscopic tumor after biopsy
- •age ≥ 18 years of age
- •Karnofsky Performance Score >=60
- •For women with childbearing potential, (and men) adequate contraception (sexual abstinence, estrogen- or gestagen containing contraceptive medication etc.)
- •Female participants: No pregnancy present (pregnancy test required)
- •Ability of subject to understand character and individual consequences of the clinical trial
- •Written informed consent (must be available before enrolment in the trial)
排除标准
- •Patients presenting with any of the following criteria will not be included in the trial:
- •distant metastases
- •refusal of the patients to take part in the study
- •previous radiotherapy of the abdomen
- •Patients who have not yet recovered from acute toxicities of prior therapies
- •Known carcinoma < 5 years ago (excluding Carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy
- •Pregnant or lactating women
- •Participation in another clinical study or observation period of competing trials, respectively
研究组 & 干预措施
Carbon Ion Radiotherapy
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
Juergen Debus
Prof. Dr. Dr. Jürgen Debus
University Hospital Heidelberg