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

Umeå University300 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Pancreas Cancer Pancreas Neoplasm Pancreas Disease Pancreas Adenocarcinoma Surgery Chemotherapy Effect

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Median Overall Survival

Median overall survival for patients with locally advanced pancreatic cancer stratified for treatment allocation

Time frame: 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

Time frame: 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 Outcomes

Oncological treatment compliance

Number of patients that complete a started oncological treatment and are able to complete regimen

Time frame: 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

Time frame: 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

Time frame: 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