NCT05356039

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
24mo left

Started Apr 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Apr 2022May 2028

First Submitted

Initial submission to the registry

March 28, 2022

Completed
22 days until next milestone

Study Start

First participant enrolled

April 19, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 2, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Expected
Last Updated

November 30, 2022

Status Verified

November 1, 2022

Enrollment Period

3 years

First QC Date

March 28, 2022

Last Update Submit

November 23, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (9)

  • Oncological treatment compliance

    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

    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

    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

    At first visit/inclusion

  • Quality of Life at 3 months after inclusion

    Quality of Life at 3 months after inclusion

  • +4 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Confirmed or suspected invasive pancreatic primary tumor
  • Tumor classified as borderline resectable or locally advanced disease according to NCCN guidelines

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Surgical Clinic at Umeå University Hospital

Umeå, 90185, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma biobanking. Tissue Microarray Construction from formalin fixed paraffin embedded tissue

MeSH Terms

Conditions

Pancreatic NeoplasmsPancreatic Diseases

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesEndocrine System Diseases

Central Study Contacts

Oskar Franklin, MD/PhD

CONTACT

Agneta Karhu

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2022

First Posted

May 2, 2022

Study Start

April 19, 2022

Primary Completion

May 1, 2025

Study Completion (Estimated)

May 1, 2028

Last Updated

November 30, 2022

Record last verified: 2022-11

Locations