Pancreatic Cancer Clinical Trial
— PREOPANC-4Official title:
Nationwide Implementation Program for Optimal Multidisciplinary Management and Resection of Locally Advanced Pancreatic Cancer (PREOPANC-4)
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.
Status | Recruiting |
Enrollment | 223 |
Est. completion date | December 31, 2030 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age 18 years or older - Pathology-confirmed (LAPC)* - CT-based non-progressive disease (RECIST criteria) after at least 4 months of systemic chemotherapy ([m]FOLFIRINOX / gemcitabine-nab-paclitaxel). Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Amsterdam UMC, locatie AMC | Amsterdam | Noord-Holland |
Lead Sponsor | Collaborator |
---|---|
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Amphia ziekenhuis, Catharina Ziekenhuis Eindhoven, Deltaplan Alvleesklierkanker, Dutch Cancer Society, Erasmus Medical Center, Heidelberg University, Isala, Jeroen Bosch Ziekenhuis, Leiden University Medical Center, M.D. Anderson Cancer Center, Maag Lever Darm Stichting, Maastricht University Medical Center, Medical Centre Leeuwarden, Medisch Spectrum Twente, NYU Langone Health, Onze Lieve Vrouwe Gasthuis, Radboud University Medical Center, UMC Utrecht, University Medical Center Groningen, University of Colorado, Denver |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Resection rate | Resection rate of the pancreatic tumor | Immediately after completing the inclusion period (December 31, 2024). | |
Primary | Overall survival (OS) | OS from time of resection (mOS, 1-year OS & 5-year OS) | After completing the follow-up period (December 31, 2029) | |
Primary | In-hospital mortality | Mortality after resection (during primary hospitalization) | Yearly assessment throughout the inclusion period | |
Primary | In-hospital major morbidity | Clavien-Dindo grade IIIa or higher major morbidity after resection (during primary hospitalization) | Yearly assessment throughout the inclusion period | |
Secondary | 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). | |
Secondary | 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. | |
Secondary | 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. |
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