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Recurrent Disease Detection After Resection of Pancreatic Adenocarcinoma Using a Standardized Surveillance Strategy
Sponsor: UMC Utrecht
Summary
A randomized controlled trial, nested within an existing prospective cohort (Dutch Pancreatic Cancer Project; PACAP) and the United Kingdom (UK) Pancreas Cancer: Observations of Practice and survival; PACOPS) according to the 'trials within cohorts' (TwiCs) design in which the effect of a standardized surveillance, with serial tumor marker testing and routine imaging, compared to current non-standardized practice, on overall survival and quality of life in patients with primary resected PDAC is investigated. The most important secondary endpoint is quality of life. Other secondary endpoints are clinical and radiological patterns of PDAC recurrence, the compliance of patients to our standardized follow-up strategy, the impact of a standardized surveillance on (eligibility for) additional treatment, and the tolerance of additional treatment. The need for this clinical trial is emphasized by the the emergence of more potent local and more effective systemic treatments for PDAC recurrence, leading to a rising interest in early diagnosis by a standardized approach to follow-up with routine imaging and serial serum tumor marker testing.
Official title: Recurrent Disease Detection After Resection of Pancreatic Adenocarcinoma Using a Standardized Surveillance Strategy: a Nationwide Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
306
Start Date
2021-03-16
Completion Date
2026-10
Last Updated
2024-09-19
Healthy Volunteers
No
Interventions
Standardized surveillance
Standardized 3-monthly surveillance with routine imaging and serum tumor marker testing.
Locations (11)
Radboud University Medical Center
Nijmegen, Gelderland, Netherlands
Maastricht UMC
Maastricht, Limburg, Netherlands
Catharina Ziekenhuis
Eindhoven, North Brabant, Netherlands
Amsterdam University Medical Center VUmc
Amsterdam, North Holland, Netherlands
Onze Lieve Vrouwe Gasthuis
Amsterdam, North Holland, Netherlands
Amsterdam University Medical Center AMC
Amsterdam, North Holland, Netherlands
Medisch Spectrum Twente
Enschede, Overijssel, Netherlands
University Medical Center Groningen
Groningen, Provincie Groningen, Netherlands
Sint Antonius Ziekenhuis
Nieuwegein, Utrecht, Netherlands
University Medical Center Utrecht
Utrecht, Utrecht, Netherlands
University of Birmingham
Birmingham, United Kingdom