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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04196816
Other study ID # RECHMPL19_0534
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date December 1, 2020

Study information

Verified date December 2020
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date December 1, 2020
Est. primary completion date March 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 95 Years
Eligibility Inclusion criteria: - 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 Exclusion Criteria: - Patient who reject the study protocol

Study Design


Locations

Country Name City State
France Uhmontpellier Montpellier

Sponsors (5)

Lead Sponsor Collaborator
University Hospital, Montpellier Association de Chirurgie hepato-bilio-pancreatique et transplantation (ACHBT), Club Français du Pancreas (CFP), Department of Digestive Surgery and Transplantation, Université de Montpellier- Nîmes, Montpellier, France, Federation de recherche en chirurgie digestive (FRENCH)

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Progression-free survival Progression-free survival (percentage of patients without recurrence) at 3 years. Progression-free survival (PFS) (time from diagnosis to time of first radiological evidence of local, regional, or distant relapse, or death due to any cause) 3 years
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