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

Recruiting

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

• Registration Number: NCT05356039
• Lead Sponsor: Umeå University

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.

Study Timeline

• Study First Submitted: 2022-03-28
• Study Start: 2022-04-19
• Study First Submitted QC: 2022-04-26
• Study First Posted: 2022-05-02
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-23
• Last Update Posted: 2022-11-30
• Primary Completion: 2025-05
• Study Completion: 2028-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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
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

Trial Locations

Locations (1)

Surgical Clinic at Umeå University Hospital; 🇸🇪 Umeå, Sweden