Pancreatic Resection in Fit Octogenarians With Nonmetastatic Pancreatic Cancer (PRONPaC)

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

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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Cancer
• Intervention / Treatment: Procedure: All types of surgical tumor resection procedures with curative intent; Procedure: No surgical resection

Detailed Description

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.

Two main research questions are addressed:

First, the study evaluates whether surgical removal of the tumor is associated with improved overall survival, particularly in patients aged 80 years and older. Patients are grouped according to whether they underwent surgery or not, and survival outcomes are compared between these groups. Analyses are adjusted for relevant patient and disease characteristics to reduce potential confounding.

Second, the study examines the association between postoperative chemotherapy and survival in patients who underwent complete tumor removal without prior treatment. This part of the analysis focuses on patients who had no remaining visible tumor after surgery and did not receive treatment before surgery.

A key methodological challenge in evaluating postoperative treatments is that only patients who recover sufficiently after surgery can receive additional therapy. This introduces a potential bias, as these patients may already have a better prognosis. To address this issue, the study applies two complementary analytical strategies.

In the first approach, survival is measured starting from the time of surgery, and patients are grouped based on whether they received postoperative treatment. In the second approach, a so-called landmark analysis is performed. In this analysis, patients who die within the first 90 days after surgery are excluded, and survival is measured starting from this fixed time point. This method helps to reduce bias related to early postoperative mortality and differences in recovery.

Statistical analyses include survival estimation using time-to-event methods and multivariable regression models to adjust for differences between patient groups. Key variables considered in the analysis include age, sex, tumor stage, and general health status.

The findings of this study are intended to provide clinically relevant evidence for treatment decision-making in older patients with pancreatic cancer. By focusing on real-world data and applying methods to address potential biases, the study aims to improve understanding of how surgery and postoperative treatment affect survival in this growing patient population.

• Study Type: Observational
• Enrollment (Actual): 2048

Contacts and Locations

Study Locations

• Germany
  • Brandenburg
    • Brandenburg an der Havel, Brandenburg, Germany, 14770
      • Medical School Brandenburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All residents of the Federal States Brandenburg and Berlin

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Neuroendocrine tumors
• Sarcomas

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients younger than 80 years	Procedure: All types of surgical tumor resection procedures with curative intent; Procedure: No surgical resection
Patients between 80 and 89 years	Procedure: All types of surgical tumor resection procedures with curative intent; Procedure: No surgical resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall Survival	1 year overall survival after index surgery

Collaborators and Investigators

• Sponsor: Medizinische Hochschule Brandenburg Theodor Fontane
• Collaborators: Clinical-Epidemiological Cancer Registry Brandenburg Berlin, Cottbus, Germany

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): October 12, 2024

Study Registration Dates

• First Submitted: April 15, 2026
• First Submitted That Met QC Criteria: April 15, 2026
• First Posted (Actual): April 21, 2026

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Octogenarians; Real-world data; Adjuvant therapy; Pancreatic resection; Postoperative Survival; ECOG performance status
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: PRONPaC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) cannot be shared. The data used in this study were obtained from a regional clinical cancer registry and are subject to strict data protection regulations. The dataset contains sensitive, potentially identifiable health information and is governed by legal restrictions that prohibit public data sharing.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No