Neoadjuvant Chemotherapy for Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma (NCT05825066) | Clinical Trial Compass
RecruitingPhase 2
Neoadjuvant Chemotherapy for Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma
United States64 participantsStarted 2023-08-01
Plain-language summary
The objective of this research is to find out what effects (good and bad), the sequence of Gemcitabine - Abraxane (nab-Paclitaxel) followed by mFOLFIRINOX, the standard chemotherapy for pancreatic cancer, has on participants and their condition. Gemcitabine - Abraxane (nab-Paclitaxel) and mFOLFIRINOX has been approved by the US Food and Drug Administration (FDA) as first line treatment for advanced pancreatic cancer. The sequence of Gemcitabine - Abraxane (nab-Paclitaxel) followed by mFOLFIRINOX has not been approved by the FDA for treatment of pancreatic cancer.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have histologically or cytologically proven adenocarcinoma of the pancreas. Patients with mixed tumor with predominant adenocarcinoma pathology can be enrolled.
* Patients with borderline resectable or locally advanced pancreatic adenocarcinoma as assessed per National Comprehensive Cancer Network (NCCN) guidelines (either pancreatic head, neck, uncinate process, or body/tail) or institutional multidisciplinary consensus.
* Age 18 or above.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
* Patients must have organ and marrow function as defined below:
* Hemoglobin ≥8 g/dL
* Absolute neutrophil count ≥1,500/mcL
* Platelets ≥100,000/mcL
* Total bilirubin ≤1.5 X institutional upper limit of normal
* AST(SGOT)/ALT(SGPT) \<2.5 X institutional upper limit of normal
* Creatinine ≤1.5 X institutional upper limit of normal or CrCL\>50
* It is acceptable to transfuse packed red blood cells (PRBC) and platelets at the time of enrollment to meet the eligibility criteria.
* If obstructive jaundice is present, consider ursodiol or a biliary drainage procedure. If the total bilirubin can be reduced or kept to less than or equal to 3 mg/dL, then this inclusion criteria is met.
* Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
* Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).
E…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
R0 Resection Rate - Borderline Resectable Prostate Cancer Participants
Timeframe: Approximately every 8 weeks, up to 9 months
2
R0 Resection Rate - Locally Advanced Prostate Cancer Participants
Timeframe: Approximately every 8 weeks, up to 9 months