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

Quality of Life Clinical Trial

— SQUARE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05356039
• Other study ID #: UmU-square
• Status: Recruiting
• Start date: April 19, 2022
• Est. completion date: May 2028

Study information

• Verified date: November 2022
• Source: Umeå University
• Contact: Oskar Franklin, MD/PhD
• Phone: +46730458558
• Email: oskar.franklin[@]umu.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 2028
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Borderline Resectable Pancreatic Adenocarcinoma
• Chemotherapy Effect
• Locally Advanced Pancreatic Adenocarcinoma
• Pancreas Adenocarcinoma
• Pancreas Cancer
• Pancreas Disease
• Pancreas Neoplasm
• Pancreatic Diseases
• Pancreatic Neoplasms
• Quality of Life
• Surgery

Locations

Country	Name	City	State
Sweden	Surgical Clinic at Umeå University Hospital	Umeå

Sponsors (6)

Lead Sponsor	Collaborator
Umeå University	Karolinska University Hospital, Lund University Hospital, Sahlgrenska University Hospital, Sweden, University Hospital, Linkoeping, University Hospital, Umeå

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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