Combining chemotherapy and radiation before surgery for localized pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 clinical trial aims to evaluate the effectiveness of a combination of two FDA-approved chemotherapy drugs, gemcitabine and nab-paclitaxel, along with radiation therapy, administered prior to surgery in patients with localized pancreatic cancer. The primary goal is to achieve an R0 resection rate of 70% or higher, indicating complete removal of cancerous tissue. Participants will receive up to four cycles of chemotherapy followed by surgery, with additional chemotherapy post-surgery. The study will also assess secondary outcomes such as disease-free survival and overall survival rates.

Why it matters

Who can join: the full rules

Inclusion Criteria (all criteria must apply):

* 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 Criteria:

* 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.

Where it's running

• Loma Linda University Health
  Loma Linda, California, United States Recruiting

Study contacts

• Principal investigator: Naveenraj Solomon, MD — Loma Linda University Cancer Center
• Study coordinator: Naveenraj Solomon, MD
• Email: nsolomon@llu.edu
• Phone: 909-558-5498

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.