- About Pancreatic Cancer
- Get Support
Caregivers
- Get Involved
- Events
- More
2021-07-01
2024-12-31
2030-12-31
223
NCT05524090
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OBSERVATIONAL
PREOPANC-4 Implementation Program for Locally Advanced Pancreatic Cancer
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: 1. Survival: After resection, mOS of 25 months, 1-year survival >90%, and 5-year survival >20%. These outcomes will be compared to the Dutch cohort of patients (2015-2020) with RECIST non-progressive LAPC after induction chemotherapy who did not undergo surgical exploration; 2. In-hospital morbidity and mortality: in-hospital/30-day mortality ≤5% and in-hospital major morbidity of <50% after resection, which will be compared with a recent Dutch cohort (2015-2020) of resected patients with borderline resectable and locally advanced pancreatic cancer after induction/neoadjuvant therapy. Secondary targets: 1. Non-inferior radical resection (R0) rate as compared to a recent Dutch cohort (2015-2020) of resected patients with borderline resectable and locally advanced pancreatic cancer after induction/neoadjuvant therapy; 2. Non-inferior quality of life, mental and physical health status, and potential side effects on the long-term follow-up, compared to a control cohort of Dutch LAPC patients; 3. Non-inferior patients' healthcare satisfaction, compared to the Dutch historical cohort of pancreatic cancer patients.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2022-08-16 | N/A | 2022-08-29 |
2022-08-29 | N/A | 2022-09-01 |
2022-09-01 | N/A | 2022-08 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : Implementation cohort 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 crit | OTHER: Implementation - International best-practice care
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Resection rate | Resection rate of the pancreatic tumor | Immediately after completing the inclusion period (December 31, 2024). |
| Overall survival (OS) | OS from time of resection (mOS, 1-year OS & 5-year OS) | After completing the follow-up period (December 31, 2029) |
| In-hospital mortality | Mortality after resection (during primary hospitalization) | Yearly assessment throughout the inclusion period |
| In-hospital major morbidity | Clavien-Dindo grade IIIa or higher major morbidity after resection (during primary hospitalization) | Yearly assessment throughout the inclusion period |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Measured at 3, 6, 9, 12, 18, and 24 months from diagnosis, followed by yearly measurements. |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Thomas F Stoop, MD Phone Number: +316 547 555 11 Email: t.f.stoop@amsterdamUMC.nl |
Study Contact Backup Name: Marc G Besselink, MD, MSc, PhD Phone Number: +316 16 15 83 45 Email: m.g.besselink@amsterdamUMC.nl |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
