Actively Recruiting
Phase I Nab-Paclitaxel Plus Gemcitabine With Proton Therapy for Locally Advanced Pancreatic Cancer (LAPC)
Led by University of Maryland, Baltimore · Updated on 2026-05-06
24
Participants Needed
2
Research Sites
404 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to determine the maximum tolerated dose of the chemotherapy drugs nab-paclitaxel and gemcitabine when combined with hypofractionated ablative proton therapy for the treatment of locally advanced pancreatic cancer. You will receive proton therapy once a day (Monday - Friday) for 3 weeks. Participants will also receive chemotherapy on each Monday of those three weeks.
CONDITIONS
Official Title
Phase I Nab-Paclitaxel Plus Gemcitabine With Proton Therapy for Locally Advanced Pancreatic Cancer (LAPC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Cytologic or histologic proof of adenocarcinoma of the pancreas
- Nonmetastatic pancreatic cancer without spread to distant lymph nodes, organs, peritoneum, or ascites
- Radiographic evidence showing tumor involvement that contraindicates surgical removal, including specific involvement of major arteries and veins
- ECOG Performance Status of 0 or 1
- Absolute neutrophil count of at least 1,000/mm3
- Platelet count of at least 100,000/mm3
- Creatinine level less than or equal to 1.5 times the upper limit of normal
- Calculated creatinine clearance greater than 45 mL/min
- Total bilirubin level less than or equal to 2 mg/dL
You will not qualify if you...
- Resectable or borderline resectable pancreatic cancer
- Prior definitive surgical removal of pancreatic cancer
- Prior abdominal radiation overlapping the study treatment area
- Prior chemotherapy except for FOLFIRINOX, Gem-Abrax, or Gem-Cap
- Grade 4 toxicity from induction chemotherapy before starting chemoradiotherapy
- More than two dose reductions during induction chemotherapy
- Use of strong CYP3A4 inhibitors or inducers without appropriate discontinuation before treatment
- Baseline neuropathy grade 2 or higher, known Gilbert's disease, or homozygosity for UGAT1A1*28 polymorphism
- Pregnant or breastfeeding, or positive pregnancy test if of childbearing potential
- Known HIV positivity on combination antiretroviral therapy
- Non-compliance with induction chemotherapy
AI-Screening
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Trial Site Locations
Total: 2 locations
1
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
2
University of Maryland Medical Center/Maryland Proton Treatment Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
Research Team
J
Jason Molitoris, MD
CONTACT
J
Jasmine A Newman, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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