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

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.

Interventions

• Standardized surveillance · OTHER

  Standardized 3-monthly surveillance with routine imaging and serum tumor marker testing.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

Inclusion criteria:

* Participation in the PACAP and PACOPS-cohort with written informed consent for being randomized in future studies
* Histologically confirmed macroscopically radical resected (R0-R1) pancreatic adenocarcinoma
* Minimum age of 18 years

Exclusion Criteria:

* Exclusion criteria for contrast-enhanced CT-scan, following the protocol of the department of radiology in each affiliated hospital
* Mentally or physically incapable of consent
* Participation in other studies with a study-specific follow-up

Sites (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