Calcium Electroporation for Early Colorectal Cancer
赞助:
Zealand University Hospital
合作者:
信息的提供 (责任方):
，
| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | September 25, 2018 | ||
| 首次发布日期e ICMJE | October 3, 2018 | ||
| 最后更新发布日期 | October 3, 2018 | ||
| 预计研究开始日期 ICMJE | October 1, 2018 | ||
| 预计主要完成日期 | May 1, 2019 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)[ Time Frame: 42 days ] Safety will be evaluated through registration of adverse events related to the treatment. CTCAE will be used |
||
| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
|
||
| 描述性信息 | |||
| 简略标题 ICMJE | Calcium Electroporation for Early Colorectal Cancer | ||
| 正式标题 ICMJE | Calcium Electroporation for Early Colorectal Cancer | ||
| 简要概况 | This is an explorative, phase I clinical trial. The aim of this study is to establish the safety and efficacy of treating patients with early colorectal cancer with calcium electroporation prior to intended curative surgery. |
||
| 详细说明 | This is an explorative, phase I clinical trial. The aim of this study is to establish the safety and efficacy of treating patients with early colorectal cancer with calcium electroporation as a down staging and immune-response enhancing treatment prior to intended curative surgery. The study involves recruitment of patients with histologically verified rectal and sigmoid colon cancer with no indication for neoadjuvant chemoradiotherapy (experimental or standard care based) prior to intended curative surgery. In total the study will involve 24 patients, of these, 12 patients with rectal cancer and 12 patients with sigmoid colon cancer. In relation to the intervention, clinical examination, blood samples, biopsies and questionnaires will be collected to evaluate safety, tumor respons and immunologic response to the treatment. Patients will be followed for one month after the elective surgery. | ||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | Phase 1 | ||
| 研究设计 ICMJE | 分配: 干预模型: Single Group Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Treatment |
||
| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
|
||
| 研究工具 |
|
||
| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
24 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | September 1, 2019 | ||
| 预计主要完成日期 | May 1, 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - • Patients must be mentally capable of understanding the information given. - Patients must give written informed consent. - Histologically verified adenocarcinoma of the rectum or sigmoid colon. - Tumor described as passable at index endoscopy. - Men or women aged at least 18 years. - Case reviewed by MDT (surgery, radiology, oncology). Case considered curable with standard surgical resection. - ASA class I-II (Classification of the American Society of Anesthesiology) Exclusion Criteria: - • Uncorrectable coagulation disorder. - Highly inflamed gastrointestinal tissue which is ulcerated and bleeding - Patients with ICD or pacemaker units. - Ongoing immunosuppressive treatment. - Patients with concomitant use of phenytoin. - Concurrent treatment with an investigational medicinal product. - Patients with any other clinical condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study or unable to comply with the study recruitments. - Advanced tumor stages, clinical UICC stage IV. - Indication for neoadjuvant chemoradiation or chemotherapy prior to surgery - Acute surgical resection. - Pregnancy | ||
| 性别 |
|
||
| 年龄 | 最小年龄：18 Years ，最大年龄：N/A | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | |||
| 管理信息 | 数据检测委员会 | Yes | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
||
| IPD 共享声明 |
|
||
| 责任方 | ， | ||
| 研究赞助商 ICMJE | Zealand University Hospital | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
|
||
| PRS 账户 | |||
| 验证日期 | September 2018 | ||
|
ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
|||
请使用微信扫码报名
京公网安备 11010102003638号