2024-08-06
2025-12-31
2026-12-31
44
NCT06423326
Emory University
Emory University
INTERVENTIONAL
Gemcitabine, Cisplatin and Nab-Paclitaxel as Neoadjuvant Treatment for Patients With Resectable or Borderline Resectable Pancreatic Cancer
This phase II trial tests how well gemcitabine, cisplatin and nab-paclitaxel given before surgery (neoadjuvant) works in treating patients with pancreatic cancer that can be removed by surgery (resectable) or that is borderline resectable. The standard treatment for resectable and borderline resectable pancreatic cancer is a combination of surgery and chemotherapy. Neoadjuvant therapy has been shown to improve overall survival compared to patients receiving surgery first. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel, an antimicrotubule agent that stops tumor cells from growing and dividing and may kill them. Nab-paclitaxel may have fewer side effects and work better than other forms of paclitaxel. Gemcitabine, cisplatin and nab-paclitaxel may be an effective neoadjuvant treatment option for patients with resectable or borderline resectable pancreatic cancer.
PRIMARY OBJECTIVE: I. Determine the major pathological response rate, feasibility and safety of biweekly gemcitabine, cisplatin and nab-paclitaxel (GCN) in the neoadjuvant setting for patients with resectable and borderline resectable pancreatic ductal adenocarcinoma. SECONDARY OBJECTIVE: I. Determine if neoadjuvant GCN increases tumoral infiltration of lymphocytes with local and systemic phenotypic features that assist in the antitumor immune response. OUTLINE: Patients receive nab-paclitaxel intravenously (IV) over 30 minutes, cisplatin IV over 60 minutes, and gemcitabine IV over 30 minutes on days 1 and 15 of each cycle. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients with stable disease, partial or complete response undergo surgical resection per standard of care. Additionally, patients undergo biopsy on study and undergo blood sample collection and computed tomography (CT) or magnetic resonance imaging (MRI) at pre-study and on study. After completion of study treatment, patients are followed up every 3-4 months for up to 24 months.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates | Results Reporting Dates | Study Record Updates |
---|---|---|
2024-04-10 | N/A | 2024-08-12 |
2024-05-16 | N/A | 2024-08-14 |
2024-05-21 | N/A | 2024-08 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Treatment (nab-paclitaxel, cisplatin, gemcitabine) Patients receive nab-paclitaxel IV over 30 minutes, cisplatin IV over 60 minutes, and gemcitabine IV over 30 minutes on days 1 and 15 of each cycle. Treatment repeats every 28 days for up to 4 cycles in the absence of disease progression or unacceptable t | PROCEDURE: Biopsy
PROCEDURE: Biospecimen Collection
DRUG: Cisplatin
PROCEDURE: Computed Tomography
DRUG: Gemcitabine
PROCEDURE: Magnetic Resonance Imaging
DRUG: Nab-paclitaxel
PROCEDURE: Pancreatic Surgical Procedure
|
Primary Outcome Measures | Measure Description | Time Frame |
---|---|---|
Pathologic response rate | Pathologic response rate will be defined by College of American Pathologists scoring system as 0 (complete response), 1 (near complete response), 2 (partial response) and 3 (poor or no response). Pathologic response rate will be reported as a proportion of 0 and 1, with and exact 90% confidence interval estimated using the Clopper-Pearson method. | At time of surgery |
Secondary Outcome Measures | Measure Description | Time Frame |
---|---|---|
Treatment completion | Feasibility will be defined as completion of all preoperative and operative therapy. Treatment completion will reported as a proportion, with an exact 95% confidence interval estimated using the Clopper-Pearson method. | Up to 24 months |
Incidence of adverse events (AEs) | AEs, with severity will be graded using National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Descriptive statistics will be reported, using frequencies and percentages for each toxicity. | Up to 28 days after last dose of study treatment |
Radiologic response rate | Radiological response rate will be defined as complete response, partial response or stable disease after study treatment evaluated using Response Evaluation Criteria in Solid Tumors version 1.1. Radiologic response rate will be reported as a proportion, with an exact 95% confidence interval estimated using the Clopper-Pearson method. | Up to 24 months |
R0 resection rate | R0 resection indicates a microscopically margin-negative resection. R0 resection rate will reported as a proportion, with an exact 95% confidence interval estimated using the Clopper-Pearson method. | At time of surgery |
Nodal status | N0, N1, and N2 will be reported using frequencies and percentages. | Up to 24 months |
Recurrence-free survival (RFS) | RFS will be estimated using the Kaplan-Meier method, and a 95% confidence interval for median RFS will be estimated using the Brookmeyer-Crowley approach. | From surgery to recurrence or death, assessed up to 24 months |
Overall survival (OS) rate | OS will be estimated using the Kaplan-Meier method, and median survival will be calculated. A 95% confidence interval will be estimated using the Brookmeyer-Crowley approach. | From study treatment start to date of death, assessed up to 24 months |
Carbohydrate antigen (CA)19-9 response | CA19-9 response will be defined as > 50% decrease from baseline will be correlated with tumor response. CA19-9 will be reported as a proportion, with an exact 95% confidence interval estimated using the Clopper-Pearson method. CA19-9 will be correlated with RFS and OS using log-rank tests and Cox proportional hazards regression. Model assumptions will be checked and verified. | Up to 24 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact Name: Mihir M. Shah, MD Phone Number: 404-778-3307 Email: [email protected] |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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