Survival, Quality of Life and Resectability in Locally Advanced Pancreatic Cancer

Study Overview
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Brief Summary
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This study aims to assess overall survival, quality of life and resection rates in locally advanced pancreatic cancer

Detailed Description
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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.

Official Title
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Survival, Quality of Life and Resectability in Locally Advanced Pancreatic Cancer - a Multicenter Prospective Observational Study

Conditions
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Pancreas Cancer, Pancreas Neoplasm, Pancreas Disease, Pancreas Adenocarcinoma, Surgery, Chemotherapy Effect, Quality of Life, Locally Advanced Pancreatic Adenocarcinoma, Borderline Resectable Pancreatic Adenocarcinoma

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Overall Survival | Median overall survival for patients with locally advanced pancreatic cancer stratified for treatment allocation | From date of inclusion until the date of death from any cause, assessed up to 72 months | 
| Resection | Rates of resection among patients with locally advanced pancreatic cancer stratified for treatment allocation | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oncological treatment compliance | Number of patients that complete a started oncological treatment and are able to complete regimen | 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 | 
| Chemotherapy response | Percentage within each RECIST strata | 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 | 
| Predictors of resectability | Logistic regression models assessing 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 | 
| Quality of Life at baseline | 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 | At first visit/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 | Quality of Life at 3 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 | Quality of Life at 6 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 9 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 12 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 24 months after inclusion |