Neoadjuvant Chemotherapy in Borderline Resectable and Locally Advanced Pancreatic Cancer

Chemotherapy Effect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04423731
• Other study ID #: 2017/1382/REK nord
• Status: Active, not recruiting
• Start date: January 1, 2018
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2022
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 251
• Est. completion date: December 31, 2025
• Est. primary completion date: October 31, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (5)

Lead Sponsor	Collaborator
Oslo University Hospital	Haukeland University Hospital, Helse Stavanger HF, St. Olavs Hospital, University Hospital of North Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of resectability in both groups (borderline and locally advanced pancreatic cancer)	Patients who undergo surgical resection will be documented	5 years
Secondary	Overall survival from time of inclusion (intention to treat)		Overall survival rate at 5 years using Kaplan-Meier survival analysis
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0		1 year after inclusion
Secondary	Overall survival following resection		Overall survival rate at 5 years using Kaplan-Meier survival analysis
Secondary	Overall survival after 1, 2, 3 and 5 years		1, 2, 3 and 5 years after inclusion
Secondary	1-year progression-free survival rate		1-year after surgical resection
Secondary	Disease-free survival		Disease-free survival at 5 years using Kaplan-Meier survival analysis
Secondary	Radiological response		2-6 months after initiation of chemotherapy
Secondary	Histopathological response		14-30 days post surgery
Secondary	R0 resection rate		14-30 days post surgery
Secondary	Complication rates after surgery classification systems)	Dindo-Clavien and ISPGS	30 and 90 days post surgery
Secondary	Completion rates of all parts of multimodal treatment		Up to 1 year after inclusion
Secondary	QoL (EORTC QLQ-30)		5 years
Secondary	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