Pancreatic Cancer ResectablePEACENCT06868693
Neoadjuvant Chemotherapy for Elderly with Pancreatic Head Cancer
An observational study of Pancreatic Cancer Resectable and Pancreatic Cancer Stage II, run by Azienda Unita Sanitaria Locale di Piacenza.
Trial summary
The goal of this observational retrospective cohort study is to evaluate the efficacy and safety of neoadjuvant chemotherapy (NAT) in elderly patients with resectable or borderline resectable (BR) pancreatic ductal adenocarcinoma (PDAC). Read more about this study
- Who is it for?
- Ages 70 to 100 years
- Conditions the study is for
- Pancreatic Cancer Resectable, Pancreatic Cancer Stage II, Neoadjuvant Therapy
- What is being tested?
- Neoadjuvant Chemotherapy (NAT) Group
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 70 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Study population: The study population consists of elderly patients (≥70 years old) diagnosed with resectable or borderline resectable (BR) pancreatic ductal adenocarcinoma (PDAC). Patients will be retrospectively identified from hospital databases and electronic medical records across multiple international and multicenter institutions. Participants included in the study have undergone either neoadjuvant chemotherapy (NAT) followed by surgery or upfront surgery (pancreaticoduodenectomy). Data will be collected from oncology, surgery, and gastroenterology units within tertiary referral centers and high-volume pancreatic cancer treatment centers. The study focuses on real-world clinical practice and aims to evaluate treatment outcomes, including overall survival, disease progression, surgical resection rates, and treatment-related toxicities, in this clinically vulnerable population.
Who may be able to join
- Patients aged ≥ 70 years
- Patients with resectable or BR PDAC who underwent curative treatment (NAT followed by surgery and upfront surgery)
- Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) > 2
- Patients able to provide informed consent, whenever possible
Who cannot join
- Patients not meeting the inclusion criteria.
- Pancreatic cancer of pancreatic body and tail.
- Patients with metastatic disease.
- Patients with locally advanced or metastatic pancreatic cancer
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Pancreatic Cancer of the Head: Effect of Neoadjuvant Chemotherapy in Elderly People - a Multicenter Observational Study
The goal of this observational retrospective cohort study is to evaluate the efficacy and safety of neoadjuvant chemotherapy (NAT) in elderly patients with resectable or borderline resectable (BR) pancreatic ductal adenocarcinoma (PDAC). The study includes patients aged ≥70 years who have undergone NAT followed by surgery or upfront surgery.
The main questions it aims to answer are:
Read more
Does NAT improve overall survival (OS) and progression-free survival (PFS) in elderly patients compared to upfront surgery? What is the impact of NAT on R0 resection rates, conversion rates in BR tumors, and the need for vascular resection? How does the toxicity profile of different NAT regimens affect treatment outcomes and patient tolerability? Researchers will compare NAT followed by surgery vs. upfront surgery to determine differences in oncologic outcomes and postoperative complications.
Participants will:
Be retrospectively identified from hospital records. Be classified based on treatment received (NAT vs. upfront surgery). Undergo data collection on tumor characteristics, treatment regimens, surgical details, and survival outcomes.
This study aims to refine patient selection criteria for NAT in elderly patients, guiding personalized treatment strategies to optimize survival and quality of life.
- Conditions
- Pancreatic Cancer Resectable, Pancreatic Cancer Stage II, Neoadjuvant Therapy, Elderly, Borderline Pancreatic Inoperable Cancer
- Being tested
- Neoadjuvant Chemotherapy (NAT) Group
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant Chemotherapy (NAT) GroupDrug
This cohort includes elderly patients (≥70 years) with resectable or borderline resectable (BR) pancreatic ductal adenocarcinoma (PDAC) who underwent neoadjuvant chemotherapy (NAT). The NAT regimens include 5-FluoroUracil, Irinotecan, Oxaliplatin (FOLFIRINOX), gemcitabine/nab-paclitaxel (GnP), and other standard chemotherapy protocols. The study aims to evaluate the impact of NAT on overall survival (OS), progression-free survival (PFS), R0 resection rates, and postoperative outcomes, as well as the toxicity profile of different NAT regimens.
| Study group | Role | What they receive |
|---|---|---|
| Upfront Surgery (UFS) Group | This cohort includes elderly patients (≥70 years) with resectable or borderline resectable (BR) pancreatic ductal adenocarcinoma (PDAC) who underwent upfront surgical resection (pancreaticoduodenectomy) without prior neoadjuvant therapy. The study will compare oncologic outcomes, including OS, PFS, R0 resection rates, and postoperative complications, between patients receiving NAT and those undergoing immediate surgery. Receives: Drug: Neoadjuvant Chemotherapy (NAT) Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
OS is defined as the time from the initiation of treatment (NAT or upfront surgery) to death from any cause. Patients still alive at the end of the study period will be censored at the last follow-up date.
Measured: Up to 2 years from treatment initiation
Secondary outcomes (5)
Progression-Free Survival (PFS)
PFS is defined as the time from the initiation of treatment to disease progression or death from any cause, whichever occurs first. Disease progression is assessed based on RECIST v1.1 criteria using imaging studies.
Measured: Up to 1 years from treatment initiation
Resection Rate and R0 Resection Rate
The proportion of patients who successfully undergo surgical resection after NAT compared to upfront surgery. Resection margins will be classified as:
R0 (complete resection, negative margins) R1 (microscopic residual disease) R2 (macroscopic residual disease)
Measured: At the time of surgery
Major Toxicities and NAT Dropout Rate
Toxicity will be evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) v4.0. The study will report grade 3-4 toxicities, dose reductions, treatment interruptions, and patient dropout rates due to adverse events.
Measured: At the end of each cycle (each cycle is 28 days)
Conversion Rate of NAT in Borderline Resectable (BR) PDAC
The proportion of patients initially classified as borderline resectable (BR) who are successfully converted to resectable status after NAT and undergo curative-intent surgery.
Measured: At the time of surgery
Vascular Resection Rate
Comparison of the frequency of vascular resections (e.g., portal vein or superior mesenteric vein resection) between the NAT and upfront surgery groups, assessing the impact of NAT on vascular involvement.
Measured: At the time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start1 Jan 2026 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Cancer ResectableStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Unita Sanitaria Locale di Piacenza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Orlandi, Azienda Unita Sanitaria Locale di Piacenza
- Investigators
- Mario Giuffrida, MD, Principal investigator, AUSL PiacenzaElena Orlandi, MD, Principal investigator, AUSL Piacenza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06868693
- Sponsor's protocol ID
- PEACE
- Acronym
- PEACE
- Status last verified
- Mar 2025
- First submitted
- 3 Mar 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pancreatic Cancer of the Head: Effect of Neoadjuvant Chemotherapy in Elderly People - a Multicenter Observational Study
- ClinicalTrials.gov ID
- NCT06868693
- Acronym / sponsor ID
- PEACE / PEACE
- Conditions
- Pancreatic Cancer Resectable, Pancreatic Cancer Stage II, Neoadjuvant Therapy, Elderly, Borderline Pancreatic Inoperable Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Azienda Unita Sanitaria Locale di PiacenzaUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Mar 2025 (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.
The goal of this observational retrospective cohort study is to evaluate the efficacy and safety of neoadjuvant chemotherapy (NAT) in elderly patients with resectable or borderline resectable (BR) pancreatic ductal adenocarcinoma (PDAC). The study includes patients aged ≥70 years who have undergone NAT followed by surgery or upfront surgery.
The main questions it aims to answer are:
Does NAT improve overall survival (OS) and progression-free survival (PFS) in elderly patients compared to upfront surgery? What is the impact of NAT on R0 resection rates, conversion rates in BR tumors, and the need for vascular resection? How does the toxicity profile of different NAT regimens affect treatment outcomes and patient tolerability? Researchers will compare NAT followed by surgery vs. upfront surgery to determine differences in oncologic outcomes and postoperative complications.
Participants will:
Be retrospectively identified from hospital records. Be classified based on treatment received (NAT vs. upfront surgery). Undergo data collection on tumor characteristics, treatment regimens, surgical details, and survival outcomes.
This study aims to refine patient selection criteria for NAT in elderly patients, guiding personalized treatment strategies to optimize survival and quality of life.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Upfront Surgery (UFS) Group | – | Drug: Neoadjuvant Chemotherapy (NAT) GroupThis cohort includes elderly patients (≥70 years) with resectable or borderline resectable (BR) pancreatic ductal adenocarcinoma (PDAC) who underwent upfront surgical resection (pancreaticoduodenectomy) without prior neoadjuvant therapy. The study will compare oncologic outcomes, including OS, PFS, R0 resection rates, and postoperative complications, between patients receiving NAT and those undergoing immediate surgery. |
Who may qualify
- Ages
- 70 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The study population consists of elderly patients (≥70 years old) diagnosed with resectable or borderline resectable (BR) pancreatic ductal adenocarcinoma (PDAC). Patients will be retrospectively identified from hospital databases and electronic medical records across multiple international and multicenter institutions. Participants included in the study have undergone either neoadjuvant chemotherapy (NAT) followed by surgery or upfront surgery (pancreaticoduodenectomy). Data will be collected from oncology, surgery, and gastroenterology units within tertiary referral centers and high-volume pancreatic cancer treatment centers. The study focuses on real-world clinical practice and aims to evaluate treatment outcomes, including overall survival, disease progression, surgical resection rates, and treatment-related toxicities, in this clinically vulnerable population.
Key inclusion criteria (4 listed)
- Patients aged ≥ 70 years
- Patients with resectable or BR PDAC who underwent curative treatment (NAT followed by surgery and upfront surgery)
- Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) > 2
- Patients able to provide informed consent, whenever possible
Key exclusion criteria (4 listed)
- Patients not meeting the inclusion criteria.
- Pancreatic cancer of pancreatic body and tail.
- Patients with metastatic disease.
- Patients with locally advanced or metastatic pancreatic cancer
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 |
|---|---|---|
| Neoadjuvant Chemotherapy (NAT) GroupThis cohort includes elderly patients (≥70 years) with resectable or borderline resectable (BR) pancreatic ductal adenocarcinoma (PDAC) who underwent neoadjuvant chemotherapy (NAT). The NAT regimens include 5-FluoroUracil, Irinotecan, Oxaliplatin (FOLFIRINOX), gemcitabine/nab-paclitaxel (GnP), and other standard chemotherapy protocols. The study aims to evaluate the impact of NAT on overall survival (OS), progression-free survival (PFS), R0 resection rates, and postoperative outcomes, as well as the toxicity profile of different NAT regimens. | Drug | Upfront Surgery (UFS) Group |
Primary outcome
Overall Survival (OS)
Time frame: Up to 2 years from treatment initiation
OS is defined as the time from the initiation of treatment (NAT or upfront surgery) to death from any cause. Patients still alive at the end of the study period will be censored at the last follow-up date.
5 secondary outcomes
Progression-Free Survival (PFS)
Time frame: Up to 1 years from treatment initiation
Resection Rate and R0 Resection Rate
Time frame: At the time of surgery
Major Toxicities and NAT Dropout Rate
Time frame: At the end of each cycle (each cycle is 28 days)
Conversion Rate of NAT in Borderline Resectable (BR) PDAC
Time frame: At the time of surgery
Vascular Resection Rate
Time frame: At the time of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: Yes
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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.
Mario Giuffrida, MD principal investigator
AUSL Piacenza
Elena Orlandi, MD principal investigator
AUSL Piacenza
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Cancer Resectable and Pancreatic Cancer Stage II, run by Azienda Unita Sanitaria Locale di Piacenza.
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mario Giuffrida, MD (+39 3931555684, mario.giuffrida4@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: Up to 2 years from treatment initiation). 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 11 Mar 2025.