Pancreatic CancerPRONPaCNCT07542782
Pancreatic Resection in Fit Octogenarians With Nonmetastatic Pancreatic Cancer
An observational study of Pancreatic Cancer, run by Medizinische Hochschule Brandenburg Theodor Fontane at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- All types of surgical tumor resection procedures with curative intent and No surgical resection
- Type of treatment
- Surgery or procedure
- How many people
- 2,048 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2017to 12 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All residents of the Federal States Brandenburg and Berlin
Who may be able to join
- 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
Who cannot join
- Neuroendocrine tumors
- Sarcomas
Trial locations and contacts
1 site in 1 country.
Germany1 site
Medical School Brandenburg
Brandenburg an der Havel, Brandenburg, 14770
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Pancreatic Cancer
- Being tested
- All types of surgical tumor resection procedures with curative intent, No surgical resection
- Keywords
- Pancreatic resection, Octogenarians, Adjuvant therapy, Postoperative Survival, Real-world data, ECOG performance status
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All types of surgical tumor resection procedures with curative intentProcedure or surgery
No surgical resectionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Patients younger than 80 years | Not described Receives: Procedure: All types of surgical tumor resection procedures with curative intent; Procedure: No surgical resection | |
| Patients between 80 and 89 years | Not described Receives: Procedure: All types of surgical tumor resection procedures with curative intent; Procedure: No surgical resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: 1 year overall survival after index surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start1 Jan 2017
- Primary completion31 Dec 2023
- Study completion12 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,048 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medizinische Hochschule Brandenburg Theodor Fontane
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical-Epidemiological Cancer Registry Brandenburg Berlin, Cottbus, Germany
- Responsible party
- Principal investigator, Rene Mantke, Medizinische Hochschule Brandenburg Theodor Fontane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07542782
- Sponsor's protocol ID
- PRONPaC
- Acronym
- PRONPaC
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pancreatic Resection in Fit Octogenarians With Nonmetastatic Pancreatic Cancer: A Population-Based Survival Analysis
- ClinicalTrials.gov ID
- NCT07542782
- Acronym / sponsor ID
- PRONPaC / PRONPaC
- Conditions
- Pancreatic Cancer
- Keywords
- Pancreatic resection, Octogenarians, Adjuvant therapy, Postoperative Survival, Real-world data, ECOG performance status
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,048 participants (actual)
- Lead sponsor
- Medizinische Hochschule Brandenburg Theodor FontaneUniversity, hospital or other
- Collaborators
- Clinical-Epidemiological Cancer Registry Brandenburg Berlin, Cottbus, Germany
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 12 Oct 2024 (actual)
- First posted
- 21 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All residents of the Federal States Brandenburg and Berlin
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Neuroendocrine tumors
- Sarcomas
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| All types of surgical tumor resection procedures with curative intent | Procedure or surgery | Patients between 80 and 89 years, Patients younger than 80 years |
| No surgical resection | Procedure or surgery | Patients between 80 and 89 years, Patients younger than 80 years |
Primary outcome
Overall Survival
Time frame: 1 year overall survival after index surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer, run by Medizinische Hochschule Brandenburg Theodor Fontane at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 1 year overall survival after index surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.