NCT04196816

Brief Summary

Pancreatic cancer is increasing in incidence and will be the second leading cause of cancer-related deaths in 2030 in the West. Only 10 to 15% of patients are eligible for curative resection with long-term survival rarely exceeding 20% at 5 years. The management of metastatic or recurrent diseases can not, unfortunately, be recommended to date because of limited data available (INCA 2019). However, recent, low-strength publications have reported encouraging results on the long-term survival of stage IV or recurrent patients. The aim of the present retrospective cohort study is to analyze results of surgery/destruction of metastatic synchronous or metachronous disease or local recurrence in patients with stage IV pancreatic cancer

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

December 10, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 12, 2019

Completed
20 days until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

December 29, 2020

Status Verified

December 1, 2020

Enrollment Period

2 months

First QC Date

December 10, 2019

Last Update Submit

December 28, 2020

Conditions

Keywords

SurgeryMetastasis surgerySurvivalMultimodal treatmentStage IV

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Overall survival at 3 years (percentage of patients alive). Overall survival (OS) (time from diagnosis until death, regardless of cause)

    3 years

Secondary Outcomes (1)

  • Progression-free survival

    3 years

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who had resection or destruction of one or more synchronous or metachronous metastases or local recurrence of pancreatic adenocarcinoma

You may qualify if:

  • \- Patients who had resection or destruction of one or more synchronous or metachronous metastases or local recurrence of pancreatic adenocarcinoma
  • Details:
  • synchronous lesions, metachrones can be included
  • all distant lesions (hepatic, pulmonary) can be included
  • documented lymph node involvement after analysis of the specimen (hepatic hilum, mesenteric root, retroperitoneal or inter-aortic-cellar) can be included
  • patients with local recurrence who underwent surgical treatment

You may not qualify if:

  • \- Patient who reject the study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • REGIS SOUCHE

    University Hospital, Montpellier

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

December 10, 2019

First Posted

December 12, 2019

Study Start

January 1, 2020

Primary Completion

March 1, 2020

Study Completion

December 1, 2020

Last Updated

December 29, 2020

Record last verified: 2020-12

Locations