Adjuvant Gemcitabine and Capecitabine Chemotherapy in Resected Pancreatic Cancer Following Neoadjuvant Chemotherapy

Pancreatic Cancer Clinical Trial

Official title: Adjuvant Gemcitabine and Capecitabine Chemotherapy in Resected Pancreatic Cancer Following Neoadjuvant Chemotherapy

Status Recruiting

Clinical Trial Summary

Primary Objectives:

To determine the disease free survival (DFS) for participants treated with post-operative adjuvant chemotherapy, as compared to neoadjuvant therapy alone.

Secondary Objectives:

To determine the clinical efficacy of the study treatment in terms of median overall survival (OS) and median disease free survival (DFS).

To assess the safety and tolerability of the study treatment regimen as measured by the adverse events rates.

To assess the quality of life in patients receiving the study treatment.

Clinical Trial Description

The purpose of the research is to compare the usual treatment approach (chemotherapy followed by surgery) to using chemotherapy followed by surgery and then more chemotherapy. This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. To decide if it is better, the study doctors will be looking to see if the study approach increases the lifespan of patients compared to the usual approach. There will be two arms of the study. Arm one will receive treatment with gemcitabine and capecitabine every 28 days for 6 cycles. Arm two be will receive standard of care observation. Participants will be asked to undergo imaging (e.g., CT) and laboratory testing to monitor for disease recurrence. The time in the study will be for 30 months. ;

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

• NCT number: NCT05415917
• Study type: Interventional
• Source: Rutgers, The State University of New Jersey
• Contact: Prateek Gulhati, MD, PhD
• Phone: 732-235-2465
• Email: pat.gulhati@rutgers.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: July 29, 2022
• Completion date: March 1, 2025