Borderline Resectable Pancreatic Adenocarcinoma, Chemotherapy Effect, Locally Advanced Pancreatic Adenocarcinoma, Pancreatectomy
Conditions
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.
Interventions
DRUGFolfirinox
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.
Sponsors
Oslo University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of resectability in both groups (borderline and locally advanced pancreatic cancer) | 5 years | Patients who undergo surgical resection will be documented |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Overall survival from time of inclusion (intention to treat) | Overall survival rate at 5 years using Kaplan-Meier survival analysis | — |
| 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) 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) |
| Histopathological response | 14-30 days post surgery | — |
Countries
Norway
Outcome results
None listed