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

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

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

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Oskar Franklin, MD/PhD; Phone Number: +46730458558; Email: oskar.franklin@umu.se
• Study Contact Backup: Name: Agneta Karhu; Email: agneta.karhu@umu.se

Study Locations

• Sweden
  • Umeå, Sweden, 90185
    • Recruiting
    • Surgical Clinic at Umeå University Hospital
    • Contact: Oskar Franklin, PhD; Phone Number: +4690785000; Email: oskar.franklin@umu.se
    • Contact: Agneta Karhu; Email: agneta.karhu@regionvasterbotten.se
    • Principal Investigator: Oskar Franklin, MD/PhD
    • Sub-Investigator: Asif Halimi, MD/PhD
    • Sub-Investigator: Stina Lindblad, MD
    • Sub-Investigator: Daniel Öhlund, MD/PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Umeå University
• Collaborators: Karolinska University Hospital; Sahlgrenska University Hospital, Sweden; University Hospital, Linkoeping; Lund University Hospital; University Hospital, Umeå

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2022
• Primary Completion (Anticipated): May 1, 2025
• Study Completion (Anticipated): May 1, 2028

Study Registration Dates

• First Submitted: March 28, 2022
• First Submitted That Met QC Criteria: April 26, 2022
• First Posted (Actual): May 2, 2022

Study Record Updates

• Last Update Posted (Actual): November 30, 2022
• Last Update Submitted That Met QC Criteria: November 23, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Adenocarcinoma; Pancreatic Neoplasms; Pancreatic Diseases
• Other Study ID Numbers: UmU-square

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No