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ENROLLING BY INVITATION
NCT04875325
NA

Recurrent Disease Detection After Resection of Pancreatic Adenocarcinoma Using a Standardized Surveillance Strategy

Sponsor: UMC Utrecht

View on ClinicalTrials.gov

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

OTHER

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