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

November 23, 2022 updated by: Umeå University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Sweden
      • Umeå, Sweden, 90185
        • Recruiting
        • Surgical Clinic at Umeå University Hospital
        • Contact:
        • Contact:
        • 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

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Median Overall Survival
Time Frame: 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
From date of inclusion until the date of death from any cause, assessed up to 72 months
Resection
Time Frame: 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
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Oncological treatment compliance
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
At first visit/inclusion
Quality of Life at 3 months after inclusion
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Umeå University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Karolinska University Hospital
Sahlgrenska University Hospital, Sweden
University Hospital, Linkoeping
Lund University Hospital
University Hospital, Umeå

Study record dates

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 19, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 28, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 26, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 2, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 30, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 23, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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