NCT02218801已完成不适用
A Prospective Colorectal Liver Metastasis Database With an Integrated Quality Assurance Program
European Organisation for Research and Treatment of Cancer - EORTC16 个研究点 分布在 12 个国家目标入组 219 人开始时间: 2015年5月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 219
- 试验地点
- 16
- 主要终点
- Number of post-operative complications
研究概览
简要总结
This prospective database has two main objectives;
- to evaluate the complication rates, 30-day and 90-day mortality from different surgical strategies for unresectable, borderline resectable or initially unresectable liver metastasis from colorectal cancer.
- to establish baseline quality parameters for different surgical strategies for unresectable, borderline and initially unresectable colorectal liver metastasis (CRLM) patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •With histologically proven colorectal adenocarcinoma with liver metastasis.
- •With unresectable, borderline or initially unresectable liver metastasis from a colorectal cancer assessed by a clinician or by a multi-disciplinary tumor board (MDT).
- •Unresectable is defined as no possibility of completely resecting all tumor due to size, location or number of deposits.
- •Borderline is defined as potentially operable but technically or biologically more challenging to resect as evaluated by the MDT.
- •Initially unresectable is defined as metastasis that have been down-sized after conversion chemotherapy and evaluated by the MDT to be resectable
- •discussed by a multidisciplinary team before surgery.
- •Participants of the MDT must include at least one liver surgeon, one radiologist and one oncologist. They will determine the resectability of the CRLM according to local practice.
- •With a possibility of a surgical procedure (resection with or without portal vein embolization, intraoperative local ablative technique or a combined approach) assessed during the MDT.
- •Age ≥ 18 years.
- •Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations.
排除标准
- •Any psychological, familial, or sociological condition potentially hampering understanding of the research project.
- •Any other malignancy other than in situ carcinoma of the cervix or non-melanoma skin cancer (unless there has been a disease-free interval of at least 5 years)
结局指标
主要结局
Number of post-operative complications
时间窗: 1 year
次要结局
- Number of post-operative complications in the first 50 patients compared to the second 50 patients(1 year)
- Overall survival after 2 years of follow-up(3 years)
- Progression free survival at 2 years(3 years)
研究者
研究点 (16)
Loading locations...
相似试验
Unknown
不适用
Metastatic Colorectal Cancer DatabaseMetastatic Colorectal CancerNCT04031625Centre Georges Francois Leclerc1,000
招募中
不适用
Bone Metastases Database of Patients Treated Surgically for Impending or Pathologic Fracture of Long BonesNeoplasm MetastasisNCT03416959Istituto Ortopedico Rizzoli120
进行中（未招募）
不适用
Metastatic Tumor Research and Outcomes NetworkMetastatic Spine TumorNCT02830451AO Innovation Translation Center960
撤回
不适用
AIMS Academy Clinical Research Network - Non Metastatic Rectal Cancer Operated on With Curative IntentNon Metastatic Rectal CancerNCT04045236Niguarda Hospital
尚未招募
不适用
NON-COlorectal Liver METastases Undergoing Liver ResectionLiver MetastasesNCT06542926Azienda Ospedaliero Universitaria Maggiore della Carita300