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临床试验/NCT07542782
NCT07542782已完成不适用

Pancreatic Resection in Fit Octogenarians With Nonmetastatic Pancreatic Cancer: A Population-Based Survival Analysis

Medizinische Hochschule Brandenburg Theodor Fontane1 个研究点 分布在 1 个国家目标入组 2,048 人开始时间: 2017年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,048
试验地点
1
主要终点
Overall Survival

研究概览

简要总结

This study looks at how different treatment approaches affect survival in older people with pancreatic cancer that has not spread to other parts of the body. In particular, it focuses on patients aged 80 years and older who are still in relatively good general health and able to carry out normal daily activities.

Pancreatic cancer is a serious disease, and surgery to remove the tumor is often the only treatment that offers a chance of longer survival. However, older patients are less likely to receive surgery, even if they are otherwise fit. Doctors may hesitate to recommend surgery mainly because of the patient's age, rather than their overall health condition. This study aims to better understand whether surgery can still be beneficial for these older patients.

The study also examines the role of additional treatment after surgery, such as chemotherapy. In real-world medical practice, not all patients receive this follow-up treatment, especially older individuals who may have a slower recovery after surgery. This can make it difficult to understand whether such treatments truly improve survival.

To answer these questions, the study uses data from a large cancer registry in Germany. It compares patients who had surgery with those who did not, and it also looks at patients who received additional treatment after surgery versus those who did not. Special methods are used to take into account that some patients may not have been able to receive further treatment because they did not recover well enough after surgery.

The results of this study are intended to help doctors make better treatment decisions for older patients with pancreatic cancer, focusing more on their overall health and less on age alone.

详细描述

This study is a retrospective, population-based cohort analysis designed to evaluate treatment outcomes in patients with non-metastatic pancreatic cancer, with a particular focus on older individuals aged 80 years and above who have a good functional status.

Pancreatic cancer is one of the most serious forms of cancer, with generally poor survival outcomes. Surgical removal of the tumor represents the only potentially curative treatment option. However, the use of surgery in elderly patients remains controversial. In routine clinical practice, treatment decisions are often influenced by chronological age rather than a patient's actual physical condition. As a result, older patients are less likely to undergo surgical treatment, even when they may be fit enough to tolerate it.

In addition to surgery, chemotherapy administered after tumor removal is commonly recommended to improve long-term outcomes. Evidence from clinical trials suggests that this additional treatment can prolong survival. However, these trials typically include highly selected patients who have recovered well from surgery and meet strict eligibility criteria. In contrast, in everyday clinical practice, many patients-especially older ones-may not receive such treatment due to complications, slower recovery, or reduced tolerance.

This study aims to address these gaps by analyzing real-world data from the Clinical-Epidemiological Cancer Registry of Berlin and Brandenburg, Germany. The registry collects standardized information on cancer diagnosis, treatments, and outcomes across both hospital and outpatient settings. Data completeness is ensured through mandatory reporting requirements and validation processes.

The study includes patients diagnosed with pancreatic cancer between January 1, 2017, and December 31, 2023. Only patients with disease that has not spread to distant organs (stages I to III) are included. To ensure comparability and reduce the influence of frailty, the analysis is limited to patients with good general condition, defined as being fully active or only slightly restricted in physical activity. Patients aged 90 years and older are excluded due to small numbers and expected heterogeneity.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of invasive pancreatic carcinoma
  • UICC stage I-III
  • No distant metastases (M0)
  • ECOG performance status 0-1
  • Diagnosis between Jan 1, 2017 and Dec 31, 2023
  • Residence in Berlin or Brandenburg

排除标准

  • Neuroendocrine tumors

研究组 & 干预措施

Patients younger than 80 years

干预措施: All types of surgical tumor resection procedures with curative intent (Procedure)

Patients younger than 80 years

干预措施: No surgical resection (Procedure)

Patients between 80 and 89 years

干预措施: All types of surgical tumor resection procedures with curative intent (Procedure)

Patients between 80 and 89 years

干预措施: No surgical resection (Procedure)

结局指标

主要结局

Overall Survival

时间窗: 1 year overall survival after index surgery

次要结局

未报告次要终点

研究者

发起方
Medizinische Hochschule Brandenburg Theodor Fontane
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rene Mantke

Principal investigator

Medizinische Hochschule Brandenburg Theodor Fontane

研究点 (1)

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