An observational study in Pancreatic Cancer, Locally Advanced Pancreatic Adenocarcinoma and Pancreatic Adenocarcinoma Non-resectable, sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-01.
Sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Observational
A prospective, nationwide, implementation program of the international standard of excellence for locally advanced pancreatic cancer (LAPC) care in the Netherlands (2021[7]-2030[6]), including a multidisciplinary training program by the four leading international expert centers.
The PREOPANC-4 project aims a safe and patient-centered implementation of the international standards of excellence for LAPC (surgery) in the Netherlands.
Rationale:
Non-metastasized locally advanced pancreatic cancer (LAPC) is diagnosed in 35% of all pancreatic cancer patients and is traditionally treated with palliative care. Recently, the multidisciplinary management of LAPC has evolved by the introduction of modern multi-agent induction chemotherapies, leading to an increased resection rate and improved outlook for five-year survival. In contrast, five-year survival after chemotherapy without surgery is virtually non-existent. In the Netherlands, the LAPC resection rate after induction chemotherapy remains low with 8% versus 25% in international centers of excellence, leading to missed opportunities for five-year survival in a selected subgroup of LAPC patients. Explanations for this large difference include the spectrum of chemotherapy use, interpretation of diagnostics, patient selection, and surgical techniques.
Objective:
A safe and patient-centered implementation of the international standards of excellence for LAPC (surgery) in the Netherlands.
Study design:
A prospective, nationwide, implementation program of the international standard of excellence for LAPC care in the Netherlands (2021[7]-2030[6]), including a multidisciplinary training program by the four leading international expert centers (i.e. University of Heidelberg, University of Colorado, NYU Langone, and MD Anderson Cancer Center). Subsequently, the three Dutch centers with the highest surgical volume and documented experience in LAPC surgery will implement this highly complex LAPC surgery in close collaboration with the other Dutch Pancreatic Cancer Group (DPCG) centers. Patients who meet the inclusion criteria will be discussed within an online (inter)national expert panel to properly select patient for surgery. In addition, the other DPCG centers can present their LAPC patients to this panel for advice about (surgical) treatment options and if these patients should be referred to the three high-volume DPCG centers for surgery. Outcomes will be compared with a historical Dutch LAPC cohort, using propensity score matching.
Study population:
Adult patients with pathology confirmed non-metastasized LAPC and non-progressive disease after at least four months of (modified) FOLFIRINOX or gemcitabine-nab-paclitaxel induction chemotherapy and fit for major surgery.
Study aim:
The primary study aim is to double the LAPC resection rate in the Netherlands from 8% to 16% with adequate survival and morbidity targets.
Primary targets:
Secondary targets:
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Adult patients with pathology confirmed non-metastasized LAPC and non-progressive disease after at least two months of (modified) FOLFIRINOX or gemcitabine-nab-paclitaxel induction chemotherapy and fit for major surgery.
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Exclusion Criteria:
Metastatic pancreatic cancer prior to induction chemotherapy.
Inclusion criteria: 1. Age ≥18 years; 2. Pathology confirmed LAPC\*; 3. CT-based non-progressive disease in accordance with the RECIST criteria after at least 4 months of systemic chemotherapy (\[m\]FOLFIRINOX or gemcitabine-nab-paclitaxel). Exclusion criteria: (1) Metastatic pancreatic cancer prior to induction chemotherapy. \*According to the Dutch Pancreatic Cancer Group (DPCG) definition: \>90 degrees arterial tumor involvement (i.e. superior mesenteric artery, celiac axis, and/or hepatic artery) and/or portovenous involvement of either \>270 degrees or occlusion.
Other: Implementation - International best-practice care
The PREOPANC-4 project aims to safely implement the international standard of excellence for LAPC management and surgery using a multidisciplinary best-practice training program, based on the experiences of four leading international expert centers (i.e. NYU Langone Health, University of Colorado, Heidelberg University, and MD Anderson Cancer Center). We hypothesize that the PREOPANC-4 implementation project will result in the improvement in multidisciplinary patient management and selection in line with current international best-practice.
Resection rate
Resection rate of the pancreatic tumor
Time frame: Immediately after completing the inclusion period (December 31, 2024).
Overall survival (OS)
OS from time of resection (mOS, 1-year OS \& 5-year OS)
Time frame: After completing the follow-up period (December 31, 2029)
In-hospital mortality
Mortality after resection (during primary hospitalization)
Time frame: Yearly assessment throughout the inclusion period
In-hospital major morbidity
Clavien-Dindo grade IIIa or higher major morbidity after resection (during primary hospitalization)
Time frame: Yearly assessment throughout the inclusion period
R0 resection rate
R0 (microscopic radical resection \>1mm) versus R1 (microscopic residual tumor ≤1mm). NB. For the anterior margin, only direct ingrowth is considered as R1.
Time frame: Immediately after completing the inclusion period (December 31, 2024).
Quality of life
EORTC QLQ-C30: global health status Outcome measures will be calculated, according to the validated questionnaire manuals.
Time frame: Measured at 3, 6, 9, 12, 18, and 24 months from diagnosis, followed by yearly measurements.
Shared decision-making: patients' healthcare satisfaction
APECC decision-making self-efficacy scale. Outcome measures will be calculated, according to the validated questionnaire manuals.
Time frame: Measured at 3, 6, 9, 12, 18, and 24 months from diagnosis, followed by yearly measurements.
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