Neoadjuvant Chemotherapy in Borderline Resectable and Locally Advanced Pancreatic Cancer

Neoadjuvant Chemotherapy in Borderline Resectable and Locally Advanced Pancreatic Cancer - A Norwegian Population Based Observational Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Chemotherapy Effect; Locally Advanced Pancreatic Adenocarcinoma; Borderline Resectable Pancreatic Adenocarcinoma; Pancreatectomy
• Intervention / Treatment: Drug: Folfirinox

• Study Type: Observational
• Enrollment (Actual): 251

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0268
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Population based cohort from a universal health care system

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Outcome Measure	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); - 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); - 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); - Symptomatic, >50% in bed, but not bedbound (Capable of only limited self-care, confined to bed or chair 50% or more of waking hours); - Bedbound (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair)	5 years

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Collaborators: University Hospital of North Norway; Helse Stavanger HF; Haukeland University Hospital; St. Olavs Hospital
• Investigators: Principal Investigator: Knut J. Labori, MD, PhD, Oslo University Hospital, Oslo, Norway

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ANTICIPATED): October 31, 2022
• Study Completion (ANTICIPATED): December 31, 2025

Study Registration Dates

• First Submitted: June 4, 2020
• First Submitted That Met QC Criteria: June 5, 2020
• First Posted (ACTUAL): June 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 27, 2022
• Last Update Submitted That Met QC Criteria: September 26, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Protective Agents; Antineoplastic Agents, Phytogenic; Micronutrients; Vitamins; Antidotes; Vitamin B Complex; Gemcitabine; Paclitaxel; Fluorouracil; Leucovorin; Folfirinox
• Other Study ID Numbers: 2017/1382/REK nord

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No