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Testing Chemotherapy and Radiation Before Surgery for Pancreatic Cancer

This study is testing a combination of two approved chemotherapy drugs, gemcitabine and nab-paclitaxel, along with radiation therapy, given before surgery for localized pancreatic cancer. The goal is to see if this approach can increase the chances of surgeons completely removing the tumor (called an R0 resection). You may be able to join if you have pancreatic adenocarcinoma that can potentially be removed by surgery, are at least 18 years old, and meet certain health requirements. The study aims for a 70% or higher R0 resection rate. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 30 participants. It is a Phase 2 study.
What's involved
You would receive up to four cycles of chemotherapy (gemcitabine and nab-paclitaxel) and radiation therapy before surgery. After surgery, you would receive up to two more cycles of the same chemotherapy.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, curative intent resection rate, is measured within two weeks prior to starting post-operative chemotherapy.

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NCT03492671

Testing the Combination of Two Approved Chemotherapy Drugs and Radiation Prior to Surgery in Localized Pancreatic Cancer

Recruiting
PHASE2Ages 18+InterventionalTreatment
Loma Linda University
~30 participants
Updated 2025-10-02 on ClinicalTrials.gov
What's tested:Gemcitabine 1000 mgnab-paclitaxelStereotactic Body Radiation Therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Curative Intent Resection (R0) rate
Measured over Within 2 weeks prior to initiation of post-operative chemotherapy.

Conditions

Pancreas Adenocarcinoma
Resectable Pancreatic Cancer

Explore related trials

Pancreatic Carcinoma

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Naveenraj Solomon, MD · PRINCIPAL_INVESTIGATOR · Loma Linda University Cancer Center

Who to contact

Naveenraj Solomon, MD
[email protected]
909-558-5498
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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, renal and hepatic function as defined by:
ANC greater or equal to 1,500 cells/mm3
Platelets greater or equal to 100,000 cells/mm3
Serum bilirubin ≤ 1.5 x upper limit of normal (ULN)
Serum creatinine ≤ 2 x ULN • ALT ≤ 5 x ULN
AST ≤ 5 x ULN
No history of prior therapy for pancreatic cancer.
No history of active infection requiring IV antibiotics at the start of study treatment
Non-pregnant and non-breast-feeding.

Exclusion

Patient has borderline resectable or metastatic disease.
History of malignancy in the last 5 years other than in situ cancer or basal or squamous cell skin cancer or malignancies cured by surgery alone or surgery plus radiotherapy and have been continuously disease-free for at least 5 years.
Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.

What this trial measures

  • Curative Intent Resection (R0) rateWithin 2 weeks prior to initiation of post-operative chemotherapy.

    Measure the rate of R0 resection with all margins microscopically clear.