NCT05415917

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Gemcitabine and Capecitabine	A chemotherapy cycle will constitute 28 days of treatment: 1. Gemcitabine: 1000 mg/m2 IV on days 1, 8, and 15 of each 28-day cycle 2. Capecitabine: 1660 mg/m2 per day orally on days 1 through 21 of each 28-day cycle.

Timeline

• Start date: 2022-07-29
• Primary completion: 2025-03-01
• Completion: 2025-03-01
• First posted: 2022-06-13
• Last updated: 2023-08-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study