Actively Recruiting
Testing the Combination of Two Approved Chemotherapy Drugs and Radiation Prior to Surgery in Localized Pancreatic Cancer
Led by Loma Linda University · Updated on 2025-10-02
30
Participants Needed
1
Research Sites
371 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this phase 2 research study is to determine whether a combination of chemotherapy drugs plus radiation therapy, given before surgery in resectable pancreactic cancer, can help to increase the chances of surgeons achieving and R0 resection. The chemotherapy drugs used are gemcitabine and nab-paclitaxel. These drugs are both approved by the FDA for use in treating adults with pancreatic adenocarcinoma. The investigational portion of this study is providing the chemotherapy drugs and radiation therapy before surgery. Primary Endpoint, R) resection rate ≥70%. Secondary Endpoints, Disease free survival, Overall survival , Perioperative mortality and morbidity.
CONDITIONS
Official Title
Testing the Combination of Two Approved Chemotherapy Drugs and Radiation Prior to Surgery in Localized Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Cytologic or histologic proof of adenocarcinoma of the pancreas.
- Localized, potentially resectable tumors.
- Greater or equal to 18 years of age.
- ECOG performance status of 0 or 1.
- Adequate hematologic function: ANC 1,500 cells/mm3, platelets 100,000 cells/mm3.
- Adequate liver function: serum bilirubin 1.5 x upper limit of normal, ALT 5 x ULN, AST 5 x ULN.
- Adequate renal function: serum creatinine 2 x ULN.
- No prior therapy for pancreatic cancer.
- No active infection requiring IV antibiotics at treatment start.
- Not pregnant or breastfeeding.
You will not qualify if you...
- Borderline resectable or metastatic disease.
- History of other malignancy within last 5 years except in situ cancer or certain skin cancers or cancers cured by surgery or surgery plus radiotherapy with at least 5 years disease-free.
- Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Loma Linda University Health
Loma Linda, California, United States, 92354
Actively Recruiting
Research Team
N
Naveenraj Solomon, MD
CONTACT
S
Shagufta Shaheen, MD
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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