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Enrolling by Invitation

NCT Number: NCT04875325

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

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.

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Key information

Conditions

Resectable Pancreatic Ductal Adenocarcinoma Recurrent Pancreatic Ductal Adenocarcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboud University Medical Center, Nijmegen, Gelderland, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standardized surveillance

Other

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

Primary outcomes

  1. Overall survival

    Time frame: 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

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

Secondary outcomes

  1. Compliance of the standardized surveillance strategy

    Time frame: Through completion of patient inclusion, an average of 1.5 years

    The percentage of patients that either accepts or refuses participation in the intervention-arm, i.e. is willing to undergo a standardized follow-up regime.

  2. Recurrence-free interval

    Time frame: 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

    The interval between the date of PDAC resection and the date of first radiological signs of recurrence, or last follow-up if recurrence is not observed.

  3. Prognostic patient specific characteristics and tumor related factors for disease recurrence

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

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

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

  5. 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

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

  6. Reasons to refrain from treatment for recurrence

    Time frame: At the time the patient is assessed eligible for additional treatment. Assessed through the study, up to 24 months

    e.g. poor condition, patients wish, deteriorated condition, progressive disease, advise treating clinician, death, wait-and-see, age.

  7. Patients' tolerance of additional treatment for PDAC recurrence as assessed by incidence of adverse events (graded according to NCI CTCAE Version 5.0)

    Time frame: Through study completion, an average of 2 years

  8. Morbidity associated with diagnostic testing assessed by the side-effects of diagnostic testing (i.e. fear of disease recurrence)

    Time frame: From date of randomization until disease recurrence or last follow-up, whichever came first, assessed up to 24 months

  9. Patient reported non-disease specific health-related Quality of Life (HRQoL) as assessed using the EQ-5D-5L

    Time frame: At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year after enrollment in the PACAP and PACOPS-cohort. Assessed through study completion, up to 24 months

    Part of the Patient Reported Outcome Measures (PROMs) that are being standardly measured in PACAP and PACOPS-participants.

  10. Overall costs of a standardized surveillance strategy versus the costs as incurred with the current non-standardized follow-up assessed according to the EQ-5D questionnaire as part of the PACAP and PACOPS-project, and calculated using to a Markov model

    Time frame: After study completion (estimated duration of 3.5 years)

  11. Patient reported chemotherapy-induced peripheral neuropathy as assessed using the EORTC QLQ-CIPN20

    Time frame: At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year after enrollment in the PACAP and PACOPS-cohort. Assessed through study completion, up to 24 months

    Part of the Patient Reported Outcome Measures (PROMs) that are being standardly measured in PACAP and PACOPS-participants.

  12. Patient reported Quality of Life as assessed using the happiness, hospital, anxiety and depression scale (HADS)

    Time frame: At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year after enrollment in the PACAP and PACOPS-cohort. Assessed through study completion, up to 24 months

    Part of the Patient Reported Outcome Measures (PROMs) that are being standardly measured in PACAP and PACOPS-participants.

  13. Patient reported Quality of Life as assessed using Exocrine Pancreatic Insufficiency (EPI) questionnaire

    Time frame: At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year after enrollment in the PACAP and PACOPS-cohort. Assessed through study completion, up to 24 months

    Part of the Patient Reported Outcome Measures (PROMs) that are being standardly measured in PACAP and PACOPS-participants.

  14. Patient reported Quality of Life as assessed using the worry of progression of cancer scale (WOPS)

    Time frame: At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year after enrollment in the PACAP and PACOPS-cohort. Assessed through study completion, up to 24 months

    Part of the Patient Reported Outcome Measures (PROMs) that are being standardly measured in PACAP and PACOPS-participants.

  15. Patient reported cancer-specific HRQoL as assessed using the EORTC QLQ-C30

    Time frame: At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year after enrollment in the PACAP and PACOPS-cohort. Assessed through study completion, up to 24 months

    Part of the Patient Reported Outcome Measures (PROMs) that are being standardly measured in PACAP and PACOPS-participants.

  16. Patient reported tumor-specific HRQoL as assessed using the EORTC LQPAN26

    Time frame: At baseline and at 3, 6, 9, 12, 18 and 24 months and every subsequent year after enrollment in the PACAP and PACOPS-cohort. Assessed through study completion, up to 24 months

    Part of the Patient Reported Outcome Measures (PROMs) that are being standardly measured in PACAP and PACOPS-participants.

Other outcomes

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

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

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

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

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

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

  4. Radiological patterns of disease recurrence assessed by information from imaging reports from the electronic patient dossier: explanatory

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

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Collaborators

  • Dutch Pancreatic Cancer Group (DPCG)
  • University of Birmingham

Registry information

Official study title

Recurrent Disease Detection After Resection of Pancreatic Adenocarcinoma Using a Standardized Surveillance Strategy: a Nationwide Randomized Controlled Trial

Acronym: RADAR-PANC

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
May 6, 2021
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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