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临床试验/NCT02082886
NCT02082886已完成不适用

Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) For Peritoneal Surface Malignancies Including Carcinomatosis or Sarcomatosis - Data Registry

Edward-Elmhurst Health System2 个研究点 分布在 1 个国家目标入组 193 人开始时间: 2014年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
193
试验地点
2
主要终点
Overall survival rate

研究概览

简要总结

In this registry study the investigators will collect data about patients' disease, treatment, and response to treatment to include in both our local and national databases. These can then be used by investigators to answer questions about cytoreductive surgery/HIPEC such as how well-tolerated or effective it is in specific populations.

详细描述

Patient Selection: The sole inclusion criteria for this study will be those consenting patients who are to undergo cytoreductive surgery followed by HIPEC.

Data Collection and Use Plan: For those patients who provide informed consent, data listed below will be collected during and after treatment. This will be entered into the PI's local database for future use and, after being de-identified, will be shared with a national database (held by the American Society of Peritoneal Surface Malignancies) to bolster the amount available for researchers looking at efficacy and outcomes such as overall survival rates, progression-free survival, and tolerability in certain populations.

Data Collected (as applicable): Age, primary tumor, dates of prior surgeries, prior chemotherapy with dates and whether it was neoadjuvant in nature, length of disease status, comorbidities, Peritoneal Surface Disease Severity Score, Peritoneal Cancer Index as determined prior to surgery, Peritoneal Cancer Index as determined during surgery, Completeness of Cytoreduction score, ascites present, blood products used, complications, length of stay in ICU and in hospital, where discharged, death within 30 days, readmission and reason, date of recurrence, treatment of recurrence, and time from procedure to death. For the HIPEC surgical procedure itself, data collected will be: date, duration, chemotherapeutic used and dose, duration of circulation, fluid temp, and flow rate.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Eligible to undergo cytoreductive surgery followed by HIPEC performed by the PI at Edward Hospital
  • Provides consent by signing informed consent form

排除标准

  • Not eligible for surgery or for potential cytoreductive surgery and/or HIPEC as determined by the PI
  • Does not consent to participate

结局指标

主要结局

Overall survival rate

时间窗: From time of treatment until death, approximately 10 years

Collect data from patients undergoing CRS/HIPEC which will be used to examine overall survival rates in specific patient populations.

次要结局

  • Rates of complications(During procedure until approximately 90 days post)
  • Progression-free survival rate(From time of treatment until time of disease progression, approximately 10 years)

研究者

发起方
Edward-Elmhurst Health System
申办方类型
Other
责任方
Sponsor

研究点 (2)

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