Clinical trial NCT05356039: Survival, Quality of Life and Resectability in Locally Advanced Pancreatic Cancer
Official title: Survival, Quality of Life and Resectability in Locally Advanced Pancreatic Cancer - a Multicenter Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreas Cancer
Pancreas Neoplasm
Pancreas Disease
Pancreas Adenocarcinoma
Surgery
Chemotherapy Effect
Quality of Life
Locally Advanced Pancreatic Adenocarcinoma
Borderline Resectable Pancreatic Adenocarcinoma
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: University Hospital, Linkoeping
name: Lund University Hospital
name: Sahlgrenska University Hospital
name: Karolinska University Hospital
name: University Hospital, Umeå
First posted: 2022-05-02
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a confirmed or suspected non-endocrine invasive pancreatic primary tumor that is classified as borderline resectable or locally advanced disease

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.

Eligibility criteria: 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

Primary outcomes:
measure: Median Overall Survival
timeFrame: From date of inclusion until the date of death from any cause, assessed up to 72 months
measure: Resection
timeFrame: 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:
measure: Oncological treatment compliance
timeFrame: 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
measure: Chemotherapy response
timeFrame: 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
measure: Predictors of resectability
timeFrame: 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
measure: Quality of Life at baseline
timeFrame: At first visit/inclusion
measure: Quality of Life at 3 months after inclusion
timeFrame: Quality of Life at 3 months after inclusion
measure: Quality of Life at 6 months after inclusion
timeFrame: Quality of Life at 6 months after inclusion
measure: Quality of Life at 9 months after inclusion
timeFrame: Quality of Life at 9 months after inclusion
measure: Quality of Life at 12 months after inclusion
timeFrame: Quality of Life at 12 months after inclusion
measure: Quality of Life at 24 months after inclusion
timeFrame: Quality of Life at 24 months after inclusion
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Surgical Clinic at Umeå University Hospital
Study officials:
References: