Menu
Enrolling by invitation NCT07241676

Early Recurrence After Surgery for Pancreatic Cancer

— Observational Pancreatic Ductal Adenocarcinoma (PDAC) Recurrent Pancreatic Adenocarcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Curative-intent resection (R0, R1).
Who it may be relevant to
Registry conditions: Pancreatic Ductal Adenocarcinoma (PDAC), Recurrent Pancreatic Adenocarcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Early Recurrence and Futility After Curative-intent Resection of Pancreatic Ductal Adenocarcinoma

Overview

The goal of this observational study is to learn about early recurrence after curative-intent surgery for pancreatic cancer. The main questions it aims to answer are: * How often does early recurrence (within 12 months after surgery) occur? * When does it happen, and at which anatomical sites (liver, lung, local, peritoneum)? * How is recurrence detected (imaging or tumor markers)? Adults with histologically confirmed pancreatic ductal adenocarcinoma who undergo curative-intent resection without distant metastases will be enrolled. Participants will be followed according to routine clinical care at each hospital, typically with imaging and CA19-9 blood tests. No study-specific interventions are required.

Detailed description

This international, prospective, multicenter observational study aims to characterize early recurrence (ER) after curative-intent resection of pancreatic ductal adenocarcinoma (PDAC). ER is defined as recurrence occurring within 12 months following surgery.

The study will assess the incidence, timing, anatomical sites, and detection mode (radiologic vs. biochemical) of ER, as well as post-recurrence treatment patterns and short-term outcomes. Secondary aims include comparison between neoadjuvant and upfront surgery cohorts, evaluation of biochemical-only recurrence, and identification of clinical or pathological factors predictive of ER.

Consecutive eligible patients will be enrolled from high-volume pancreatic surgery centers worldwide and followed according to institutional standards of care, typically involving routine imaging and CA19-9 surveillance. Standardized data will be prospectively collected to describe recurrence patterns and post-recurrence management. No study-specific interventions are required.

Interventions

  • Procedure Curative-intent resection (R0, R1)
    Standard-of-care surgical resection for pancreatic ductal adenocarcinoma, as determined by the multidisciplinary team. No study-specific interventions are mandated.

Primary outcome measures

  • Incidence, timing, mode of detection, and anatomical site of early recurrence [Time frame: Within 12 months post-surgery]
Secondary outcome measures (5)
  • Comparison of ER patterns in patients treated with neoadjuvant therapy versus upfront surgery [Time frame: 12 months post-surgery]
  • Incidence and clinical impact of biochemical-only recurrence [Time frame: 12 months post-surgery]
  • Post-recurrence treatment strategies and short-term survival outcomes [Time frame: From recurrence up to 24 months post-surgery]
  • Clinical and pathological predictors of early recurrence [Time frame: Up to 12 months post-surgery]
  • Validation of futility criteria for upfront surgery patients [Time frame: Within 6 months post-surgery]

Eligibility criteria

Inclusion criteria

  • Age ≥18 years
  • Histologically confirmed pancreatic ductal adenocarcinoma (PDAC)
  • Undergoing curative-intent resection (R0 or R1)
  • No evidence of distant metastasis at the time of surgery
  • Availability of preoperative CA19-9 value and pancreas-protocol CT or MRI
  • Ability to provide written informed consent

Exclusion criteria

  • Withdrawal of informed consent
  • Pathological diagnosis other than PDAC (e.g., neuroendocrine tumor, acinar cell carcinoma, invasive IPMN)
  • Surgery performed for palliative or diagnostic purposes only
  • Intraoperative discovery of unresectable disease or distant metastases
  • Gross residual disease (R2 resection)
  • Incomplete clinical or radiologic follow-up precluding recurrence assessment
  • Absence of adequate preoperative contrast-enhanced pancreas-protocol CT or MRI preventing accurate staging and metastatic evaluation
  • Interval >9 months between two consecutive follow-up visits
  • Major protocol deviations or insufficient data, as judged by the site investigator

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • University of Padova — Padova

Identifiers

NCT: NCT07241676 · AOP3909

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗