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

NCT ID: NCT04875325

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 306 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-16
• Study Completion Date: 2026-10-31

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.

Detailed Description

Rationale: Radical resection combined with (neo)adjuvant chemotherapy offers the best chances for long-term survival for patients with resectable localized pancreatic ductal adenocarcinoma (PDAC). However, even after radical resection, almost all patients will experience local and/or distant disease recurrence after sufficient follow-up, mostly within 2 years. There is a lack of evidence based effective therapeutic options for the significant group of patients with local recurrence only, in terms of improved survival and/or quality of life. In the case of metastatic disease effective chemotherapy has shown to improve survival, but with a median gain survival of 3-4 months. Taken together, this had led to a hesitant attitude towards postoperative recurrence-focused follow-up. Therefore, in most European countries, including the Netherlands, a standardized approach to follow-up after surgery for PDAC is lacking. Furthermore, current PDAC guidelines regarding follow-up are based on expert opinion and other low-level evidence. However, the emergence of more potent local and more effective systemic treatments for PDAC has led to a rising interest in early diagnosis of PDAC recurrence. To detect PDAC recurrence at an early stage and identify patients with good performance status who are most likely to benefit from additional (experimental) treatment, a standardized approach to follow-up with routine imaging and serial serum tumor marker testing is needed. To determine whether early detection of recurrence can lead to improved survival and quality of life, further studies are warranted.

Objective: The main objective is to evaluate the impact of a standardized surveillance, with serial tumor marker testing and routine imaging, on overall survival and quality of life in patients with primary resected PDAC, compared to current non-standardized practice.

Study design: 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.

Study population: PACAP or PACOPS-participants with histologically confirmed radical resection (R0-R1) of PDAC, who provided informed consent for being randomized in future studies.

Interventions: Standardized surveillance, existing of clinical evaluation, serum cancer antigen (CA) 19-9 testing, and contrast-enhanced computed tomography (CT-) imaging of chest and abdomen every 3 months during the first 2 years after surgery.

Comparison: Non-standardized clinical follow-up.

Endpoints: The main study endpoint is overall survival. 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.

Conditions

Resectable Pancreatic Ductal Adenocarcinoma; Recurrent Pancreatic Ductal Adenocarcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Standardized surveillance

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

Group Type: EXPERIMENTAL

Standardized surveillance

Intervention Type: OTHER

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

Non-standardized surveillance

Non-standardized surveillance strategy according to current clinical practice.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Standardized surveillance

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

Intervention Type: OTHER

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dutch Pancreatic Cancer Group (DPCG)

UNKNOWN

Sponsor Role: collaborator

University of Birmingham

OTHER

Sponsor Role: collaborator

UMC Utrecht

OTHER

Sponsor Role: lead

Responsible Party

Prof. dr. I.Q. Molenaar, MD, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

I. Q. Molenaar, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Regional Academic Cancer Center Utrecht (RACU)

H. C. van Santvoort, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Regional Academic Cancer Center Utrecht (RACU)

M. G.H. Besselink, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Academic Medical Center - Cancer Center Amsterdam

L. A. Daamen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Regional Academic Cancer Center Utrecht (RACU)

Locations

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

Countries

Netherlands; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 38902836 (View on PubMed)

Other Identifiers

20-762

Identifier Type: OTHER

Identifier Source: secondary_id

NL67115.041.18

Identifier Type: -

Identifier Source: org_study_id