This phase II trial compares usual treatment (chemotherapy followed by surgery) to using chemotherapy followed by surgery and then more chemotherapy in patients with pancreatic cancer that has been removed by surgery (resected). Chemotherapy drugs, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving gemcitabine and capecitabine after surgery may kill any remaining tumor cells.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05415917.
PRIMARY OBJECTIVE:
I. To determine the disease free survival (DFS) for patients treated with post-operative adjuvant chemotherapy, as compared to neoadjuvant therapy alone.
SECONDARY OBJECTIVES:
I. To determine the clinical efficacy of the study treatment in terms of median overall survival (OS) and median disease free survival (DFS).
II. To assess the safety and tolerability of the study treatment regime as measured by the adverse events rates.
III. To assess the quality of life in patients receiving the study treatment.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive gemcitabine hydrochloride intravenously (IV) over 120 minutes on days 1, 8, and 15 of each cycle and capecitabine orally (PO) twice daily (BID) on days 1-21 of each cycle. Treatment repeats every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity.
ARM II: Patients undergo observation.
After completion of study treatment, patients are followed every 3 months for 5 years.
Lead OrganizationRutgers Cancer Institute of New Jersey
Principal InvestigatorPrateek Gulhati
