Failure to Adjuvant Therapy After Pancreatic Resection for Pancreatic Cancer

Completed

• Conditions: Pancreatic Malignant Neoplasm Primary

• Registration Number: NCT03788382
• Lead Sponsor: Universita di Verona

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-12-21
• Study First Submitted QC: 2018-12-25
• Study First Posted: 2018-12-27
• Study Start: 2019-01-01
• Primary Completion: 2024-02-28
• Study Completion: 2024-02-28
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 317

Inclusion Criteria

• Histologic diagnosis of pancreatic cancer

Exclusion Criteria

• Non exocrine pancreatic tumors
• Periampullary malignancies

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of patients who fail to receive adjuvant therapy and reasons for that	6 months	The amount of patients who will not receive adjuvant therapy after pancreatic resection for malignancy (when do indication exists) will be recorded
Rate of patients who fail to complete adjuvant therapy and reasons for that	9 months	The amount of patients who will not complete adjuvant therapy after pancreatic resection for malignancy will be recorded

Secondary Outcome Measures

Name	Time	Method
Disease free survival of patients enrolled	18 months

Trial Locations

Locations (1)

University of Verona Hospital; 🇮🇹 Verona, Italy