Pancreas CancerSQUARENCT05356039
Survival, Quality of Life and Resectability in Locally Advanced Pancreatic Cancer
An observational study of Pancreas Cancer and Pancreas Neoplasm, run by Umeå University at 1 site in Sweden.
Trial summary
This study aims to assess overall survival, quality of life and resection rates in locally advanced pancreatic cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer, Pancreas Neoplasm, Pancreas Disease
- How many people
- 300 participants
- Where
- 1 siteSweden
- Study dates
- 19 Apr 2022to May 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a confirmed or suspected non-endocrine invasive pancreatic primary tumor that is classified as borderline resectable or locally advanced disease
Who may be able to join
- Confirmed or suspected invasive pancreatic primary tumor
- Tumor classified as borderline resectable or locally advanced disease according to NCCN guidelines
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Agneta Karhu contact
Sweden1 site, 1 recruiting
- Recruiting
Surgical Clinic at Umeå University Hospital
Umeå, 90185
Oskar Franklin, PhD, +4690785000, oskar.franklin@umu.se
Agneta Karhu, agneta.karhu@regionvasterbotten.se
About this study
Official title: 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
Read the 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.
- Conditions
- Pancreas Cancer, Pancreas Neoplasm, Pancreas Disease, Pancreas Adenocarcinoma, Surgery, Chemotherapy Effect
- Medical subject headings
- Pancreatic Neoplasms, Pancreatic Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Overall Survival
Median overall survival for patients with locally advanced pancreatic cancer stratified for treatment allocation
Measured: 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
Measured: 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 outcomes (9)
Oncological treatment compliance
Number of patients that complete a started oncological treatment and are able to complete regimen
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Quality of Life at 24 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start19 Apr 2022
- Primary completionMay 2025 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Linkoeping, Lund University Hospital, Sahlgrenska University Hospital, Karolinska University Hospital, University Hospital, Umeå
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05356039
- Sponsor's protocol ID
- UmU-square
- Acronym
- SQUARE
- Status last verified
- Nov 2022
- First submitted
- 28 Mar 2022
- Last updated
- 30 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survival, Quality of Life and Resectability in Locally Advanced Pancreatic Cancer - a Multicenter Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05356039
- Acronym / sponsor ID
- SQUARE / UmU-square
- Conditions
- Pancreas Cancer, Pancreas Neoplasm, Pancreas Disease, Pancreas Adenocarcinoma, Surgery, Chemotherapy Effect
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- University Hospital, Linkoeping, Lund University Hospital, Sahlgrenska University Hospital, Karolinska University Hospital, University Hospital, Umeå
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to assess overall survival, quality of life and resection rates in locally advanced pancreatic cancer
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a confirmed or suspected non-endocrine invasive pancreatic primary tumor that is classified as borderline resectable or locally advanced disease
Key inclusion criteria (2 listed)
- Confirmed or suspected invasive pancreatic primary tumor
- Tumor classified as borderline resectable or locally advanced disease according to NCCN guidelines
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
9 secondary outcomes
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
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
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
Quality of Life at baseline
Time frame: 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 at 6 months after inclusion
Time frame: 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 at 12 months after inclusion
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
Related trials for Pancreas Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Agneta Karhu contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreas Cancer and Pancreas Neoplasm, run by Umeå University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oskar Franklin, MD/PhD (+46730458558, oskar.franklin@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Overall Survival (time frame: From date of inclusion until the date of death from any cause, assessed up to 72 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2022.