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 Type
OBSERVATIONAL
Enrollment
251
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.
Oslo University Hospital
Oslo, Norway
Rate of resectability in both groups (borderline and locally advanced pancreatic cancer)
Patients who undergo surgical resection will be documented
Time frame: 5 years
Overall survival from time of inclusion (intention to treat)
Time frame: 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
Time frame: 1 year after inclusion
Overall survival following resection
Time frame: Overall survival rate at 5 years using Kaplan-Meier survival analysis
Overall survival after 1, 2, 3 and 5 years
Time frame: 1, 2, 3 and 5 years after inclusion
1-year progression-free survival rate
Time frame: 1-year after surgical resection
Disease-free survival
Time frame: Disease-free survival at 5 years using Kaplan-Meier survival analysis
Radiological response
Time frame: 2-6 months after initiation of chemotherapy
Histopathological response
Time frame: 14-30 days post surgery
R0 resection rate
Time frame: 14-30 days post surgery
Complication rates after surgery classification systems)
Dindo-Clavien and ISPGS
Time frame: 30 and 90 days post surgery
Completion rates of all parts of multimodal treatment
Time frame: Up to 1 year after inclusion
QoL (EORTC QLQ-30)
Time frame: 5 years
Performance status - Eastern Cooperative Oncology Group (ECOG)
0 - Asymptomatic (Fully active, able to carry on all predisease activities without restriction) 1. \- 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) 2. \- 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) 3. \- Symptomatic, \>50% in bed, but not bedbound (Capable of only limited self-care, confined to bed or chair 50% or more of waking hours) 4. \- Bedbound (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair)
Time frame: 5 years
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