Clinical trial NCT04423731: Neoadjuvant Chemotherapy in Borderline Resectable and Locally Advanced Pancreatic Cancer (NORPACT-2)
Official title: Neoadjuvant Chemotherapy in Borderline Resectable and Locally Advanced Pancreatic Cancer - a Norwegian Population Based Observational Study (NORPACT-2)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Locally Advanced Pancreatic Adenocarcinoma
Chemotherapy Effect
Borderline Resectable Pancreatic Adenocarcinoma
Pancreatectomy
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 251
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population based cohort from a universal health care system

Brief summary: This is a Norwegian prospective observational study that evaluates the resectability rate in patients with borderline resectable and locally advanced pancreatic cancer who received neoadjuvant chemotherapy in a population based cohort. Eligible patients are treated with neoadjuvant 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.


Eligibility criteria: Inclusion Criteria:

* borderline resectable or locally advanced adenocarcinoma of the pancreas (NCCN, version 2, 2015)
* Nx, M0 (UICC 8 th version, 2016)
* cytological or histological confirmation of adenocarcinoma
* age \> 18 year and considered fit for major surgery
* written informed consent
* considered able to receive the study-specific chemotherapy

Exclusion Criteria:

* co-morbidity precluding pancreatectomy
* chronic neuropathy ≥ grade 2
* WHO performance score \> 2
* granulocyte count \< 1500 per cubic millimetre
* platelet count \< 100 000 per cubic millimetre
* serum creatinine \> 1.5 UNL (upper limit normal range)
* albumin \< 2,5 g/dl
* 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

Primary outcomes:
measure: Rate of resectability in both groups (borderline and locally advanced pancreatic cancer)
timeFrame: 5 years
Secondary outcomes:
measure: Overall survival from time of inclusion (intention to treat)
timeFrame: Overall survival rate at 5 years using Kaplan-Meier survival analysis
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 1 year after inclusion
measure: Overall survival following resection
timeFrame: Overall survival rate at 5 years using Kaplan-Meier survival analysis
measure: Overall survival after 1, 2, 3 and 5 years
timeFrame: 1, 2, 3 and 5 years after inclusion
measure: 1-year progression-free survival rate
timeFrame: 1-year after surgical resection
measure: Disease-free survival
timeFrame: Disease-free survival at 5 years using Kaplan-Meier survival analysis
measure: Radiological response
timeFrame: 2-6 months after initiation of chemotherapy
measure: Histopathological response
timeFrame: 14-30 days post surgery
measure: R0 resection rate
timeFrame: 14-30 days post surgery
measure: Complication rates after surgery classification systems)
timeFrame: 30 and 90 days post surgery
measure: Completion rates of all parts of multimodal treatment
timeFrame: Up to 1 year after inclusion
measure: QoL (EORTC QLQ-30)
timeFrame: 5 years
measure: Performance status - Eastern Cooperative Oncology Group (ECOG)
timeFrame: 5 years
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital, Oslo, Norway
name: Knut J. Labori, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Farnes I, Lund-Iversen M, Aabakken L, Verbeke C, Labori KJ. Molecular testing for personalized therapy is underutilized in patients with borderline resectable and locally advanced pancreatic cancer - real world data from the NORPACT-2 study. Scand J Gastroenterol. 2024 Sep;59(9):1093-1096. doi: 10.1080/00365521.2024.2373115. Epub 2024 Jul 3.
citation: Farnes I, Paulsen V, Verbeke CS, Tonnesen CJ, Aabakken L, Labori KJ. Performance and safety of diagnostic EUS FNA/FNB and therapeutic ERCP in patients with borderline resectable and locally advanced pancreatic cancer - results from a population-based, prospective cohort study. Scand J Gastroenterol. 2024 Apr;59(4):496-502. doi: 10.1080/00365521.2023.2290456. Epub 2023 Dec 21.
citation: 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.