Buffalo, NYNCT06821997Now EnrollingIRB Ready

Borderline Resectable Pancreatic Ductal Adenocarcinoma Clinical Trial in Buffalo, NY

Access cutting-edge borderline resectable pancreatic ductal adenocarcinoma treatment through this phase 2 clinical trial at a research site in Buffalo. Study-provided care at no cost to qualified participants.

Sponsored by Roswell Park Cancer Institute

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Expert Care in Buffalo

Access borderline resectable pancreatic ductal adenocarcinoma specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related borderline resectable pancreatic ductal adenocarcinoma treatment provided free

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Check if you qualify for this borderline resectable pancreatic ductal adenocarcinoma clinical trial in Buffalo, NY

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Why Participate?

  • No-Cost Study Care

  • Local to Buffalo

    Convenient for NY residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Buffalo site if eligible
  4. 4Begin participation

About This Borderline Resectable Pancreatic Ductal Adenocarcinoma Study in Buffalo

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.

Sponsor: Roswell Park Cancer Institute

Who Can Participate

Inclusion Criteria

Age ≥ 18 years of age
Have histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC) that is borderline resectable (BR) using the National Comprehensive Cancer Network criteria
Have a documented Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
Absolute neutrophil count (ANC) ≥ 1,500 cells/uL without the use of hematopoietic growth factors
Platelet count ≥ 100,000 cells/uL
Hemoglobin ≥ 9 g/dL
Plasma total bilirubin ≤ upper limit of normal (ULN) (biliary drainage is allowed for biliary obstruction)
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
Creatine clearance of \> 30 mL/min (per Cockroft-Gault equation)
Plasma albumin ≥ 3 g/dL
Have measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
Participant must understand the investigational nature of this study and sign an independent ethics committee/institutional review board approved written informed consent form (ICF) prior to receiving any study related procedure

Exclusion Criteria

Patients who have had previous chemotherapy or radiotherapy for PDAC
Patients with resectable, unresectable, or metastatic PDAC
Presence of germline glucuronosyltransferase (UGT) 1A1 (\*28 or \*6) or dihydropyrimidine dehydrogenase (DPD) polymorphisms (DPYD\*2A \[rs3918290, c.1905+1G\>A, IVS14+1G\>A\], c.2846A\>T \[rs67376798, D949V\], c.1679T\>G \[rs55886062, DPYD\*13, I560S\], and c.1236G\>A \[rs56038477, E412E, in haplotype B3\]) known to significantly impact CPT-11 and fluorouracil metabolism and associated with increased risk for toxicities
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant or nursing female participants
Unwilling or unable to follow protocol requirements
Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Buffalo?

Yes, this clinical trial (NCT06821997) has an active research site in Buffalo, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Borderline Resectable Pancreatic Ductal Adenocarcinoma Treatment Options in Buffalo, NY

If you're searching for borderline resectable pancreatic ductal adenocarcinoma treatment options in Buffalo, NY, this clinical trial (NCT06821997) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Buffalo research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced borderline resectable pancreatic ductal adenocarcinoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all borderline resectable pancreatic ductal adenocarcinoma clinical trials near you to find additional studies recruiting in your area.

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