Multicenter Retrospective Analysis of Adjuvant Chemotherapy Regimen in IPMN derived PDAC
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- whether an adjuvant chemotherapy regimen (monotherapy gemcitabine vs. combination gemcitabine vs. FOLFIRINOX) is associated with overall survival in patients with respected IPMN-derived PDAC.
研究概览
简要总结
A specific subtype of pancreatic cancer called ‘IPMN (intraductal papillary mucinous neoplasms) derived PDAC’ (pancreatic ductal adenocarcinoma), is known to have better prognosis. The role of chemotherapy in this tumor in adjuvant setting (after surgery) slowly getting established. The present study will compare three types of adjuvant chemotherapy one called gemcitabine, another one with combo gemcitabine, and one called FOLFIRINOX after resection in IPMN associated PDAC.
At present the chemotherapy regimens for IPMN derived PDAC are extrapolated from what is being used in the data available for the other/standard PDAC (non IMPN derived). Hence, although adjuvant chemotherapy is useful, the appropriate regimen is yet to be identified for IPMN associated PDAC.
In this multicenter retrospective study, group of hospitals treating this cancer with different types of chemotherapy regimens will participate by providing data on long term outcomes. Our main goal is to see if one of these chemotherapy types helps people live longer after surgery for IPMN- derived PDAC.
We will look at records of patients who had surgery for IPMN-derived PDAC between 2005 to 2022 and were at least 18-year-old. We will not take those patients data that had any other serious complications along with the surgery.
In the data collection we will collect information like age, medical history, treatment etc; and then we will see if there is a difference in how long people live or how each of chemotherapy works.
We’re hoping this study will give us a clearer picture of which chemotherapy regimen works best for IPMN-derived PDAC.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with resected IPMN derived PDAC from 2005 to 2022.
排除标准
- •Patients below 18 years of age -Patients with concomitant PDAC, metastatic disease at time of resection, Neoadjuvant therapy or 90 day mortality.
结局指标
主要结局
whether an adjuvant chemotherapy regimen (monotherapy gemcitabine vs. combination gemcitabine vs. FOLFIRINOX) is associated with overall survival in patients with respected IPMN-derived PDAC.
时间窗: Overall survival will be calculated as the time between date of the surgery to the date of the last known follow-up visit or death 5 years
次要结局
- Recurrence free survival(Recurrence free survival will be calculated from the date of surgery to the date of documented cancer recurrence or death, whichever comes first)
研究者
Dr Shailesh Shrikhande
TATA MEMORIAL HOSPITAL