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2022-04-19
2025-05
2028-05
300
NCT05356039
Umeå University
Umeå University
OBSERVATIONAL
Survival, Quality of Life and Resectability in Locally Advanced Pancreatic Cancer
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2022-03-28 | N/A | 2022-11-23 |
2022-04-26 | N/A | 2022-11-30 |
2022-05-02 | N/A | 2022-11 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|
| Primary Outcome Measures | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Oskar Franklin, MD/PhD Phone Number: +46730458558 Email: oskar.franklin@umu.se |
Study Contact Backup Name: Agneta Karhu Phone Number: Email: agneta.karhu@umu.se |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
