Neoadjuvant Chemotherapy in Borderline Resectable and Locally Advanced Pancreatic Cancer

Study Overview
=================
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.

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

Conditions
-----------------
Locally Advanced Pancreatic Adenocarcinoma, Chemotherapy Effect, Borderline Resectable Pancreatic Adenocarcinoma, Pancreatectomy

Intervention / Treatment
-----------------
* Drug: Folfirinox


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Folfirinox|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.|

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 |