Surgery for Pancreatic Cancer With Oligo-Metastasis

Pancreatic Cancer Clinical Trial

— SPaM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04196816
• Other study ID #: RECHMPL19_0534
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms
• Pancreatic Surgery

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