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Recruiting NCT05356039

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

Observational Pancreas Cancer Pancreas Neoplasm Pancreas Disease Pancreas Adenocarcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Pancreas Cancer, Pancreas Neoplasm, Pancreas Disease, Pancreas Adenocarcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Median Overall Survival [Time frame: 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]
Secondary outcome measures (9)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Sweden · 1 center
  • Surgical Clinic at Umeå University Hospital — Umeå

Identifiers

NCT: NCT05356039 · UmU-square

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗