Neoadjuvant Chemotherapy In Borderline Resectable And Locally Advanced Pancreatic Cancer (NORPACT-2)

Study Overview

Neoadjuvant Chemotherapy in Borderline Resectable and Locally Advanced Pancreatic Cancer (NORPACT-2)

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.

N/A

Locally Advanced Pancreatic Adenocarcinoma
Chemotherapy Effect
Borderline Resectable Pancreatic Adenocarcinoma
Pancreatectomy

DRUG: Folfirinox

2017/1382/REK nord

Study Record Dates

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
First Submitted 2020-06-04	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-11-18
First Submitted that Met QC Criteria 2020-06-05	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-11-20
First Posted (ACTUAL) 2020-06-09	Results First Posted N/A	Last Verified 2024-11

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
Rate of resectability in both groups (borderline and locally advanced pancreatic cancer)	Patients who undergo surgical resection will be documented	5 years

Secondary Outcome Measures	Measure Description	Time Frame
Overall survival from time of inclusion (intention to treat)		Overall survival rate at 5 years using Kaplan-Meier survival analysis
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0		1 year after inclusion
Overall survival following resection		Overall survival rate at 5 years using Kaplan-Meier survival analysis
Overall survival after 1, 2, 3 and 5 years		1, 2, 3 and 5 years after inclusion
1-year progression-free survival rate		1-year after surgical resection
Disease-free survival		Disease-free survival at 5 years using Kaplan-Meier survival analysis
Radiological response		2-6 months after initiation of chemotherapy
Histopathological response		14-30 days post surgery
R0 resection rate		14-30 days post surgery
Complication rates after surgery classification systems)	Dindo-Clavien and ISPGS	30 and 90 days post surgery
Completion rates of all parts of multimodal treatment		Up to 1 year after inclusion
QoL (EORTC QLQ-30)		5 years
Performance status - Eastern Cooperative Oncology Group (ECOG)	0 - Asymptomatic (Fully active, able to carry on all predisease activities without restriction) 1. - Symptomatic but completely ambulatory (Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature. For example, light housework, office work) 2. - Symptomatic, <50% in bed during the day (Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours) 3. - Symptomatic, >50% in bed, but not bedbound (Capable of only limited self-care, confined to bed or chair 50% or more of waking hours) 4. - Bedbound (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair)	5 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

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:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Knut J. Labori, MD, PhD, Oslo University Hospital, Oslo, Norway

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
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.
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.

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Clinical Trial Record