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

NCT04875325 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 306

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

  • Resectable Pancreatic Ductal Adenocarcinoma
  • Recurrent Pancreatic Ductal Adenocarcinoma

Interventions

OTHER

Standardized surveillance

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

Sponsors & Collaborators

  • Dutch Pancreatic Cancer Group (DPCG)

    collaborator UNKNOWN

  • University of Birmingham

    collaborator OTHER

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • I. Q. Molenaar, MD, PhD · Regional Academic Cancer Center Utrecht (RACU)

  • H. C. van Santvoort, MD, PhD · Regional Academic Cancer Center Utrecht (RACU)

  • M. G.H. Besselink, MD, PhD · Academic Medical Center - Cancer Center Amsterdam

  • L. A. Daamen, MD, PhD · Regional Academic Cancer Center Utrecht (RACU)

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-16
Primary Completion
2026-10-31
Completion
2026-10-31

Countries

  • Netherlands
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04875325 on ClinicalTrials.gov