Failure to Adjuvant Therapy After Pancreatic Resection for Pancreatic Cancer

Pancreatic Malignant Neoplasm Primary Clinical Trial

— FOUNTAIN  

Official title:

Failure to Adjuvant Therapy After Pancreatic Resection for Pancreatic Cancer: a Real Life Scenario

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03788382
• Other study ID #: FOUNTAIN
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: February 28, 2024

Study information

• Verified date: May 2024
• Source: Universita di Verona
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to evaluate the rate of patients submitted to pancreatic resection for pancreatic cancer, who fail to access to adjuvant therapy or do not complete adjuvant therapy. The purpose is to give an overview concerning the most frequent conditions and/or reasons associated with failure or omission of adjuvant therapy.

Description:

This prospective observational study will evaluate all patients submitted to pancreatic resection for pancreatic cancer.

The rate of omission to adjuvant therapy and rate of failure of completion of adjuvant therapy will be evaluated as primary outcomes. As secondary outcomes, survival analyses will be performed to investigate whether these factors influence prognosis, that will be evaluated through a disease free survival analysis at 18-months. Epidemiological and perioperative data will be analyzed to identify conditions associated with the primary outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 317
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologic diagnosis of pancreatic cancer

Exclusion Criteria:

• Non exocrine pancreatic tumors

• Periampullary malignancies

Related Conditions & MeSH terms

• Neoplasms
• Pancreatic Malignant Neoplasm Primary

Locations

Country	Name	City	State
Italy	University of Verona Hospital	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Universita di Verona

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients who fail to receive adjuvant therapy and reasons for that	The amount of patients who will not receive adjuvant therapy after pancreatic resection for malignancy (when do indication exists) will be recorded	6 months
Primary	Rate of patients who fail to complete adjuvant therapy and reasons for that	The amount of patients who will not complete adjuvant therapy after pancreatic resection for malignancy will be recorded	9 months
Secondary	Disease free survival of patients enrolled		18 months