A New Clinical Pathway for Personalized Management of Borderline Resectable and Locally Advanced Pancreatic Cancer

Официальное название

A New Clinical Pathway for Personalized Management of Borderline Resectable and Locally Advanced Pancreatic Cancer - Norwegian Pancreatic Cancer Trial-3 (NORPACT 3)

Обзор

NORPACT-3 is a nationwide, Norwegian single arm prospective study that evaluates the resectability rates and survival in patients with borderline resectable and locally advanced pancreatic cancer who received primary chemotherapy. Eligible patients are treated with primary chemotherapy possibly followed by surgical exploration and resection. All Norwegian centres performing pancreatic surgery have agreed to collaborate in this trial. The assignment of the medical intervention is not at the discretion of the investigator, but follow the national Norwegian guidelines regarding diagnostic work up, oncological and surgical treatment and follow up. The primary aim is a national resection rate of 50% in BRPC and 15% in LAPC in patients initiating primary chemotherapy, with adequate overall survival and morbidity/mortality (after resection median overall survival of 24 months, 1 year survival 80%, and 5 year survival \>20% + 90 day postoperative mortality ≤5%, 90-day postoperative major morbidity (Clavien Dindo grade 3) ≤40%).

Вмешательства

• Препарат Chemotherapy
  The choice of chemotherapy regimen follows national guidelines, preferably mFOLFIRINOX or gemcitabine-nab-paclitaxel.
• Диагностический тест Radiology
  PET/CT is optional. PET/CT will be offered as a part of the diagnostic work up at baseline and one additional scan after a minimum of two months of chemotherapy.
• Процедура Pancreatectomy
  Surgery is scheduled within 4 weeks after the last neoadjuvant infusion. Resection will be performed as a standard or pylorus-preserving pancreatoduodenectomy (PD), distal pancreatectomy (DP) with splenectomy, or total pancreatectomy (TP) with splenectomy, and with or without venous or arterial resection and reconstruction.
• Процедура Endoscopy
  Endoscopic ultrasound fine-needle biopsy to establish the diagnosis with histopathology and to obtain an adequate sample for molecular pathology (KRAS status (mutation or wild type), microsatellite instability (MSI)).

Первичные конечные точки

• Resection rate (of the pancreatic tumour) [Срок оценки: From November 2024-December 2027]

Вторичные конечные точки (9)

• Overall survival [Срок оценки: From November 2024-December 2027]
• Mortality after surgical resection [Срок оценки: From November 2024-December 2027]
• Morbidity after surgical resection [Срок оценки: From November 2024-December 2027]
• Number of patients evaluated at national MDT undergoing resection [Срок оценки: From November 2024-December 2027]
• Adverse events [Срок оценки: From November 2023-December 2027]
• R0 resection rate [Срок оценки: From November 2023-December 2027]
• Quality of life EORTC QLQ-C30 [Срок оценки: Measured at baseline, 3, 6, and 12 months from diagnosis, followed by yearly measurements.]]
• Quality of life EORTC QLQ-PAN26 [Срок оценки: Measured at baseline, 3, 6, and 12 months from diagnosis, followed by yearly measurements.]
• Quality of life EQ-5D-5L [Срок оценки: Measured at baseline, 3, 6, and 12 months from diagnosis, followed by yearly measurements.]

Критерии участия

Критерии включения

• Borderline resectable or locally advanced adenocarcinoma of the pancreas (NCCN, version 2, 2021) (Appendix 3)
• Nx, M0 (UICC 8th version, 2016)
• Cytological or histological confirmation of adenocarcinoma
• Age >18 year
• Considered able to receive primary chemotherapy and possible surgery
• Written informed consent

Критерии исключения

• Co-morbidity or performance status precluding primary chemotherapy
• Co-morbidity or performance status precluding pancreatectomy
• Female patients in child-bearing age not using adequate contraception, pregnant or lactating women
• Mental or physical disorders that could interfere with treatment of with the provision of informed consent
• Any reason why, in the opinion of the investigator, the patient should not participate

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Норвегия · 5 центров

• Haukeland University Hospital — Bergen
• Stavanger University Hospital — Stavanger
• University Hospital of North Norway — Tromsø
• St. Olavs Hospital, Trondheim University Hospital — Trondheim
• Oslo University Hospital — Oslo

Публикации

• Boggi U, Kauffmann EF, Napoli N, Barreto SG, Besselink MG, Fusai GK, Hackert T, Hilal MA, Marchegiani G, Salvia R, Shrikhande SV, Truty M, Werner J, Wolfgang C, Bannone E, Capretti G, Cattelani A, Coppola A, Cucchetti A, De Sio D, Di Dato A, Di Meo G, Fiorillo C, Gianfaldoni C, Ginesini M, Hidalgo Salinas C, Lai Q, Miccoli M, Montorsi R, Pagnanelli M, Poli A, Ricci C, Sucameli F, Tamburrino D, Vit PMID 38684573
• Springfeld C, Ferrone CR, Katz MHG, Philip PA, Hong TS, Hackert T, Buchler MW, Neoptolemos J. Neoadjuvant therapy for pancreatic cancer. Nat Rev Clin Oncol. 2023 May;20(5):318-337. doi: 10.1038/s41571-023-00746-1. Epub 2023 Mar 17. PMID 36932224
• Stoop TF, Theijse RT, Seelen LWF, Groot Koerkamp B, van Eijck CHJ, Wolfgang CL, van Tienhoven G, van Santvoort HC, Molenaar IQ, Wilmink JW, Del Chiaro M, Katz MHG, Hackert T, Besselink MG; International Collaborative Group on Locally Advanced Pancreatic Cancer. Preoperative chemotherapy, radiotherapy and surgical decision-making in patients with borderline resectable and locally advanced pancreati PMID 38036745
• Farnes I, Kleive D, Verbeke CS, Aabakken L, Issa-Epe A, Smastuen MC, Fosby BV, Dueland S, Line PD, Labori KJ. Resection rates and intention-to-treat outcomes in borderline and locally advanced pancreatic cancer: real-world data from a population-based, prospective cohort study (NORPACT-2). BJS Open. 2023 Nov 1;7(6):zrad137. doi: 10.1093/bjsopen/zrad137. PMID 38155512

Идентификаторы

NCT: NCT06944587 · REK sør-øst D 733339 · 2023010 · 279530-2023

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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