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OpenTrials
Completed

NCT Number: NCT04196816

Surgery for Pancreatic Cancer With Oligo-Metastasis

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

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Key information

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Overall survival

    Time frame: 3 years

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

Secondary outcomes

  1. Progression-free survival

    Time frame: 3 years

    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)

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • Association de Chirurgie hepato-bilio-pancreatique et transplantation (ACHBT)
  • Club Français du Pancreas (CFP)
  • Federation de recherche en chirurgie digestive (FRENCH)
  • Université Montpellier

Registry information

Official study title

Surgery/Destruction for Stage IV Pancreatic Cancer With Oligo-Metastatic Disease

Acronym: SPaM

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 12, 2019
Registry last updated
Dec 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.