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Recruiting

NCT Number: NCT05356039

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

Recruiting

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Key information

Conditions

Pancreas Cancer Borderline Resectable Pancreatic Adenocarcinoma Chemotherapy Effect Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Locally Advanced Pancreatic Adenocarcinoma Neoplasms Neoplasms by Site Pancreas Adenocarcinoma Pancreas Disease Pancreas Neoplasm Pancreatic Diseases Pancreatic Neoplasms Quality of Life Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Surgical Clinic at Umeå University Hospital

Umeå, 90185, Sweden

Location status: Recruiting

Location contact

Agneta Karhu

CONTACT

[email protected]

Asif Halimi, MD/PhD

SUB_INVESTIGATOR

Daniel Öhlund, MD/PhD

SUB_INVESTIGATOR

Oskar Franklin, MD/PhD

PRINCIPAL_INVESTIGATOR

Oskar Franklin, PhD

CONTACT

[email protected]

+4690785000

Stina Lindblad, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Agneta Karhu

CONTACT

[email protected]

Oskar Franklin, MD/PhD

CONTACT

[email protected]

+46730458558

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Collaborators

  • Karolinska University Hospital
  • Lund University Hospital
  • Sahlgrenska University Hospital
  • University Hospital, Linkoeping
  • University Hospital, Umeå

Registry information

Official study title

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

Acronym: SQUARE

Important dates

Study start
2022
Primary completion
2025
Study completion
2028
First posted
May 2, 2022
Registry last updated
Nov 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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