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

NCT04423731 | Active Not Recruiting

• 1 other identifier: 2017/1382/REK nord
• Study Type: observational
• Target: 251
• Locations: 1 country
• Sites: 1

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.

Conditions

Locally Advanced Pancreatic Adenocarcinoma; Chemotherapy Effect; Borderline Resectable Pancreatic Adenocarcinoma; Pancreatectomy

Outcome Measures

Primary Outcomes (1)

• Rate of resectability in both groups (borderline and locally advanced pancreatic cancer)

  Patients who undergo surgical resection will be documented

  5 years

Secondary Outcomes (13)

• 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

Interventions

Folfirinox DRUG

Neoadjuvant chemotherapy is given according to different regimens, preferably FOLFIRINOX according to the recommendations in the national Norwegian guidelines. The choice of chemotherapy regimen is decided by the treating oncologist.

Also known as: Gemcitabine/nab-paclitaxel, Gemcitabine, 5-FU (fluorouracil) and leucovorin, FLOX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Population based cohort from a universal health care system

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital

Oslo, 0268, Norway

Location

Related Publications (3)

• 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.

  PMID: 38957079 BACKGROUND

• 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.

  PMID: 38126766 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Interventions

folfirinox; Gemcitabine; Fluorouracil; Leucovorin

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Uracil; Pyrimidinones; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Officials

• Knut J. Labori, MD, PhD

  Oslo University Hospital, Oslo, Norway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant surgeon MD, PhD

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 9, 2020
• Study Start: January 1, 2018
• Primary Completion: October 31, 2022
• Study Completion: December 31, 2025
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)