NCT04194268已完成不适用
Pancreatic Cancer and Carbon Ion Radiotherapy
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- survival
研究概览
简要总结
Irradiation of non-operable pancreatic cancer with carbon ions (C12). This therapy is expected to be more effective than the current Gold Standard of photon irradiation applied in the case of non-operable pancreatic cancer.
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
- •Histologically confirmed, inoperable primary or local recurrent pancreatic cancer
- •Written informed consent (must be available before enrollment in the trial)
- •Karnofsky performance score > 60 or ECOG-status 0/1 (at least: patient should be able to take care of himself, although daily-life activity or work is not possible)
- •Age ≥ 18 years
排除标准
- •No clear difference between tumor edge and upper gastrointestinal tract in baseline imaging
- •Extensive lymphatic metastases
- •Disability of subject to understand character and individual consequences of the clinical trial
- •Distant metastases
- •Previous radiotherapy of the upper abdomen
- •Active medical implants (e.g. pacemaker, defibrillator), contradicting radiotherapy at HIT
- •Participation in another clinical study or observation period of competing trials, respectively
研究组 & 干预措施
Interventional arm
Experimental
Carbon Ion Radiation 12 x 4 Gy (RBE) within 2 weeks
干预措施: Carbon Ion (Radiation)
结局指标
主要结局
survival
时间窗: 12 month after radiation
overall survival
次要结局
- toxicity outcomes(48 Month after radiatoin)
- Blood Parameters CEA(48 Month after radiation)
- survival(12 month after radiation)
- Blood Parameters Ca 19-9(48 Month after radiation)
- Quality of life (QLQ) EORTC QLQ C30(48 Month after radiation)
- Quality of life EORTC QLQ Pan26(48 Month after radiation)
研究者
Juergen Debus
Head of Department
University Hospital Heidelberg
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Carbon Ion Radiotherapy for Recurrent Pancreatic Cancer Post SurgeryPancreatic CarcinomaNCT05830019Shanghai Proton and Heavy Ion Center49
招募中
不适用
Carbon ion radiotherapy for refractory malignant tumorrefractory malignant tumorJPRN-UMIN000014512Gunma University Heavy Ion Medical Center50
终止
不适用
Capecitabine and Radiation Therapy in Advanced Pancreatic CancerPancreatic CancerNCT00176735University of Michigan Rogel Cancer Center
Unknown
2 期
Cone-beam CT Guided Stereotactic Radiation Therapy for Locally Advanced Pancreatic CancerPancreatic CancerNCT01898741UMC Utrecht30
进行中（未招募）
不适用
Radio-/Chemotherapie des PankreaskarzinomsRadio-/Chemotherapy of pancreas carcinoma - PaCaEUCTR2009-011968-11-DETechnische Universität Dresden