Neoadjuvant Chemotherapy in Borderline Resectable and Locally Advanced Pancreatic Cancer

Sponsor

Oslo University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04423731

Collaborator

Haukeland University Hospital (Other), St. Olavs Hospital (Other), University Hospital of North Norway (Other), Helse Stavanger HF (Other)

250

Enrollment

Location

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Locally Advanced Pancreatic Adenocarcinoma Chemotherapy Effect Borderline Resectable Pancreatic Adenocarcinoma Pancreatectomy	Drug: Folfirinox

Study Design

Study Type:

Observational

Anticipated Enrollment :

250 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2018

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2025

Outcome Measures

Primary Outcome Measures

Rate of resectability in both groups (borderline and locally advanced pancreatic cancer) [5 years]
Patients who undergo surgical resection will be documented

Secondary Outcome Measures

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) [30 and 90 days post surgery]
Dindo-Clavien and ISPGS
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) [5 years]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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