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

Launched by LOMA LINDA UNIVERSITY · Apr 3, 2018

Keywords

ClinConnect Summary

This clinical trial is exploring whether a combination of two chemotherapy drugs, gemcitabine and nab-paclitaxel, along with radiation therapy, can improve outcomes for patients with localized pancreatic cancer before they undergo surgery. The goal is to help surgeons successfully remove the cancer and achieve what is known as an R0 resection, meaning no cancer cells are left behind. This study is currently recruiting participants who are 18 years or older, have confirmed pancreatic adenocarcinoma, and have tumors that can potentially be surgically removed.

Eligible participants will receive the chemotherapy and radiation therapy before their surgery. Throughout the study, doctors will monitor various health outcomes, including how well the treatment works and any side effects. It’s important to note that individuals with certain medical conditions or previous cancer treatments may not qualify for this trial. If you or a loved one is interested in learning more, discussing eligibility and potential benefits with a healthcare provider is a good next step.

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Eligibility criteria

• 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.