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

NCT04875325 | Enrolling By Invitation DMC

• 2 other identifiers: NL67115.041.1820-762
• Study Type: interventional
• Target: 306
• Locations: 2 countries
• Sites: 11

Brief 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

Keywords

Standardized Surveillance; Follow-up; CA 19-9; Computed Tomography Scan

Outcome Measures

Primary Outcomes (1)

• Overall survival

  The interval between the date of PDAC resection and either death from any cause or last follow-up.

  From date of PDAC resection until date of death from any cause or date of last follow-up, whichever came first, assessed up to 24 months

Secondary Outcomes (16)

• Compliance of the standardized surveillance strategy

  Through completion of patient inclusion, an average of 1.5 years

• Recurrence-free interval

  From date of PDAC resection until date of first radiological signs of recurrence, or last follow-up if recurrence is not observed, whichever came first, assessed up to 24 months

• Prognostic patient specific characteristics and tumor related factors for disease recurrence

  From date of randomization until disease recurrence or last follow-up, assessed up to 24 months

• Role of serum tumor marker testing in detecting recurrent PDAC assessed by the calculated diagnostic accuracy values

  From date of randomization until disease recurrence or last follow-up, assessed up to 24 months

• Eligibility for additional (experimental) treatment at the time of recurrence diagnosis based on the ECOG or Karnofsky performance state, or inclusion criteria for study-related treatment of recurrence

  At the time of recurrence diagnosis. Assessed through the study, up to 24 months

Other Outcomes (4)

• Clinical patterns of disease recurrence assessed by the patients symptoms as reported in the electronic patient dossier: explanatory

  From date of randomization until disease recurrence or last follow-up, assessed up to 24 months

• Clinical patterns of disease recurrence assessed by physicial examination as reported in the electronic patient dossier: explanatory

  From date of randomization until disease recurrence or last follow-up, assessed up to 24 months

• Clinical patterns of disease recurrence assessed by blood test results as reported in the electronic patient dossier: explanatory

  From date of randomization until disease recurrence or last follow-up, assessed up to 24 months

Study Arms (2)

Standardized surveillance

EXPERIMENTAL

Standardized surveillance strategy with routine imaging and serum tumor marker testing.

Other: Standardized surveillance

Non-standardized surveillance

NO INTERVENTION

Non-standardized surveillance strategy according to current clinical practice.

Interventions

Standardized surveillance OTHER

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

Standardized surveillance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Mentally or physically incapable of consent
• Participation in other studies with a study-specific follow-up

Sponsors & Collaborators

• UMC Utrecht: lead
• Dutch Pancreatic Cancer Group (DPCG): collaborator
• University of Birmingham: collaborator

Study Sites (11)

Radboud University Medical Center

Nijmegen, Gelderland, 6525 GA, Netherlands

Location

Maastricht UMC

Maastricht, Limburg, 6229 HX, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, North Brabant, 5623 EJ, Netherlands

Location

Amsterdam University Medical Center VUmc

Amsterdam, North Holland, 1081 HV, Netherlands

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, North Holland, 1091 AC, Netherlands

Location

Amsterdam University Medical Center AMC

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Medisch Spectrum Twente

Enschede, Overijssel, 7512 KZ, Netherlands

Location

University Medical Center Groningen

Groningen, Provincie Groningen, 9713 GZ, Netherlands

Location

Sint Antonius Ziekenhuis

Nieuwegein, Utrecht, 3435 CM, Netherlands

Location

University Medical Center Utrecht

Utrecht, Utrecht, 3584 CX, Netherlands

Location

University of Birmingham

Birmingham, B15 2TT, United Kingdom

Location

Related Publications (1)

• Daamen LA, van Goor IWJM, Groot VP, Andel PCM, Brosens LAA, Busch OR, Cirkel GA, Mohammad NH, Heerkens HD, de Hingh IHJT, Hoogwater F, van Laarhoven HWM, Los M, Meijer GJ, de Meijer VE, Pande R, Roberts KJ, Stoker J, Stommel MWJ, van Tienhoven G, Verdonk RC, Verkooijen HM, Wessels FJ, Wilmink JW, Besselink MG, van Santvoort HC, Intven MPW, Molenaar IQ; Dutch Pancreatic Cancer Group. Recurrent disease detection after resection of pancreatic ductal adenocarcinoma using a recurrence-focused surveillance strategy (RADAR-PANC): protocol of an international randomized controlled trial according to the Trials within Cohorts design. Trials. 2024 Jun 20;25(1):401. doi: 10.1186/s13063-024-08223-5.

  PMID: 38902836 DERIVED

Study Officials

• I. Q. Molenaar, MD, PhD

  Regional Academic Cancer Center Utrecht (RACU)

  PRINCIPAL INVESTIGATOR

• H. C. van Santvoort, MD, PhD

  Regional Academic Cancer Center Utrecht (RACU)

  PRINCIPAL INVESTIGATOR

• M. G.H. Besselink, MD, PhD

  Academic Medical Center - Cancer Center Amsterdam

  PRINCIPAL INVESTIGATOR

• L. A. Daamen, MD, PhD

  Regional Academic Cancer Center Utrecht (RACU)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Trials within Cohorts (TwiCs)

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: May 6, 2021
• Study Start: March 16, 2021
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Access Criteria: Upon request.

Locations

NL (10); GB (1)