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

Compliance of the standardized surveillance strategy

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.

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

Recurrence-free interval

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.

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

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

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

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

Reasons to refrain from treatment for recurrence

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

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

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

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

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

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

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

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)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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