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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-00732 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| I-4064824 | Other Identifier | Roswell Park Cancer Institute |
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This phase II trial tests how well liposomal irinotecan, oxaliplatin, 5-fluorouracil and leucovorin (NALIRIFOX) before surgery works in treating patients with pancreatic ductal adenocarcinoma that is close to major blood vessels, but is still potentially removable by surgery (borderline resectable). Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and deoxyribonucleic acid (DNA) repair and may kill tumor cells. Liposomal irinotecan is a form of the anticancer drug irinotecan that is contained inside very tiny, fat-like particles. Liposomal irinotecan may have fewer side effects and work better than other forms of the drug. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's DNA and may kill tumor cells. 5-fluorouracil, a type of antimetabolite, stops cells from making DNA and it may kill tumor cells. Leucovorin, a form of folic acid, is used to lessen the toxic effects of substances that block the action of folic acid. It is a type of chemoprotective agent and a type of chemosensitizing agent. Giving NALIRIFOX before surgery may improve the chance of successful surgery and decrease the chance of the cancer returning after surgery in patients with borderline resectable pancreatic ductal adenocarcinoma.
PRIMARY OBJECTIVE:
I. To determine the antitumor efficacy of the combination of irinotecan sucrosofate (liposomal irinotecan), oxaliplatin and infusional fluorouracil (5-fluorouracil)/leucovorin calcium (leucovorin) (NALIRIFOX) in patients with borderline resectable pancreatic ductal adenocarcinoma.
SECONDARY OBJECTIVES:
I. To evaluate clinical efficacy and tolerability of the proposed treatment regimen.
II. To determine the safety of liposomal irinotecan, oxaliplatin and infusional fluorouracil in patients with borderline resectable pancreatic ductal adenocarcinoma.
EXPLORATORY OBJECTIVES:
I. To evaluate blood-based biomarkers predictive of short- and long-term outcomes.
II. To generate tumor tissue-based biomarkers predictive of short- and long-term outcomes.
OUTLINE:
Patients receive liposomal irinotecan intravenously (IV) over 90 minutes, oxaliplatin IV over 120 minutes, leucovorin IV over 30 minutes and fluorouracil IV over 48 hours on day 1 of each cycle. Cycles repeat every 14 days for 4-8 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo surgical resection 4-8 weeks after the last treatment dose. Starting 4-12 weeks after surgery, patients receive liposomal irinotecan, oxaliplatin, leucovorin, and fluorouracil for up to 4 additional cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo computed tomography (CT) and blood sample collection throughout the study.
After completion of study treatment, patients are followed up within 30 days, every 3-6 months for 2 years, then every 6-12 months for up to 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (NALIRIFOX) | Experimental | Patients receive liposomal irinotecan IV over 90 minutes, oxaliplatin IV over 120 minutes, leucovorin IV over 30 minutes and fluorouracil IV over 48 hours on day 1 of each cycle. Cycles repeat every 14 days for 4-8 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo surgical resection 4-8 weeks after the last treatment dose. Starting 4-12 weeks after surgery, patients receive liposomal irinotecan, oxaliplatin, leucovorin, and fluorouracil for up to 4 additional cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT and blood sample collection throughout the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo blood sample collection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major pathologic response (MPR) | MPR will be defined as either complete pathologic response or minimal residual cancer based on the American College of Pathology system. The MPR status will be summarized using frequencies and relative frequencies. | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Will be assessed using Response Evaluation Criteria in Solid Tumors 1.1. ORR will be summarized using frequencies and relative frequencies. Estimates of rates will be obtained with 90% credible regions obtained by Jeffrey's prior method. | Up to 5 years |
| CA19-9 response rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christos Fountzilas | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Recruiting | Buffalo | New York | 14263 | United States |
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| Computed Tomography | Procedure | Undergo CT |
|
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| Fluorouracil | Drug | Given IV |
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| Irinotecan Sucrosofate | Drug | Given IV |
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| Leucovorin Calcium | Drug | Given IV |
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| Oxaliplatin | Drug | Given IV |
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| Surgical Procedure | Procedure | Undergo surgical resection |
|
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Will be summarized using frequencies and relative frequencies. Estimates of rates will be obtained with 90% credible regions obtained by Jeffrey's prior method. |
| Up to 5 years |
| Carcinoembryonic antigen response rate | Will be summarized using frequencies and relative frequencies. Estimates of rates will be obtained with 90% credible regions obtained by Jeffrey's prior method | Up to 5 years |
| Positive margin resection rate | Will be summarized using frequencies and relative frequencies. Estimates of rates will be obtained with 90% credible regions obtained by Jeffrey's prior method | Up to 5 years |
| Disease-free survival | Will be summarized using standard Kaplan-Meier methods, where estimates of the median times will be obtained with 90% confidence intervals. | From start of neoadjuvant therapy until disease progression, subsequent therapy, death due to any cause, or last follow-up, assessed up to 5 years |
| Overall survival | Will be summarized using standard Kaplan-Meier methods, where estimates of the median times will be obtained with 90% confidence intervals | From start of neoadjuvant therapy until death due to any cause, or last follow-up, assessed up to 5 years |
| Incidence of adverse events | Will be described and graded using National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Will be summarized by attribution and grade using frequencies and relative frequencies. | Up to 30 days after the last intervention, or until the event has resolved, the study participant is lost to follow-up, the start of a new treatment, or until the study investigator assesses the event(s) as stable or irreversible |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D005472 | Fluorouracil |
| C029917 | dehydroftorafur |
| C584112 | irinotecan sucrosofate |
| D002955 | Leucovorin |
| D000077150 | Oxaliplatin |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005575 | Formyltetrahydrofolates |
| D013763 | Tetrahydrofolates |
| D005492 | Folic Acid |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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