Borderline Resectable Pancreatic Adenocarcinoma, Chemotherapy Effect, Locally Advanced Pancreatic Adenocarcinoma, Pancreas Adenocarcinoma, Pancreas Cancer, Pancreas Disease, Pancreas Neoplasm, Quality of Life, Surgery
Conditions
Brief summary
This study aims to assess overall survival, quality of life and resection rates in locally advanced pancreatic cancer
Detailed description
This is a multicenter pragmatic prospective observational study including Nordic hospitals treating patients with borderline resectable and locally advanced pancreatic cancer. Eligibility will be assessed at regional multidisciplinary tumor boards. Patients with borderline resectable and locally advanced (non-endocrine) pancreatic cancer according to the National Comprehensive Cancer Network (NCCN) and the International Study Group of Pancreatic Surgery (ISGPS) are eligible for inclusion. The study is observational. Quality of life will be assessed in all study participants. The primary outcomes are exploration rates, resection rates and overall survival.
Interventions
None listed
Sponsors
University Hospital, Linkoeping
Lund University Hospital
Sahlgrenska University Hospital
Karolinska University Hospital
University Hospital, Umeå
Umeå University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed or suspected invasive pancreatic primary tumor * Tumor classified as borderline resectable or locally advanced disease according to NCCN guidelines
Exclusion criteria
* Suspected endocrine tumor * Suspected non-pancreatic periampullary tumor * Distant metastasis * Age \< 18 years * Patient unable to understand verbal or written information interfering with informed consent or treatment * Mental or organic disorder interfering with informed consent or treatments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Median Overall Survival | From date of inclusion until the date of death from any cause, assessed up to 72 months | Median overall survival for patients with locally advanced pancreatic cancer stratified for treatment allocation |
| Resection | From the time of inclusion to end of study follow up or date of death from any cause, whichever came first, up to 72 months | Rates of resection among patients with locally advanced pancreatic cancer stratified for treatment allocation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Predictors of resectability | From the time of inclusion to end of study follow up or date of death from any cause, whichever came first, up to 72 months | Logistic regression models assessing predictors of resectability |
| Quality of Life at baseline | At first visit/inclusion | Quality of life assessed with EORTC QLQ C30 focused on self-reported Global Health Score ranging from 1 to 7 where a higher number indicates better self-experienced health |
| Quality of Life at 3 months after inclusion | Quality of Life at 3 months after inclusion | Quality of life assessed with EORTC QLQ C30 focused on self-reported Global Health Score ranging from 1 to 7 where a higher number indicates better self-experienced health |
| Oncological treatment compliance | From the time of inclusion to end of study follow up or date of death from any cause, whichever came first, up to 72 months | Number of patients that complete a started oncological treatment and are able to complete regimen |
| Quality of Life at 9 months after inclusion | Quality of Life at 9 months after inclusion | Quality of life assessed with EORTC QLQ C30 focused on self-reported Global Health Score ranging from 1 to 7 where a higher number indicates better self-experienced health |
| Quality of Life at 12 months after inclusion | Quality of Life at 12 months after inclusion | Quality of life assessed with EORTC QLQ C30 focused on self-reported Global Health Score ranging from 1 to 7 where a higher number indicates better self-experienced health |
| Quality of Life at 24 months after inclusion | Quality of Life at 24 months after inclusion | Quality of life assessed with EORTC QLQ C30 focused on self-reported Global Health Score ranging from 1 to 7 where a higher number indicates better self-experienced health |
| Quality of Life at 6 months after inclusion | Quality of Life at 6 months after inclusion | Quality of life assessed with EORTC QLQ C30 focused on self-reported Global Health Score ranging from 1 to 7 where a higher number indicates better self-experienced health |
| Chemotherapy response | From the time of inclusion to end of study follow up or date of death from any cause, whichever came first, up to 72 months | Percentage within each RECIST strata |
Countries
Sweden
Contacts
Primary ContactOskar Franklin, MD/PhD
Backup ContactAgneta Karhu
Outcome results
None listed