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

RecruitingPhase 2Ages 18 Years - anyAllLoma Linda University
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In plain words

What the trial is, and whether it could suit you

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 โ‰ฅ70%. Secondary Endpoints, Disease free survival, Overall survival , Perioperative mortality and morbidity.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ค 1.5 x upper limit of normal (ULN) * Serum creatinine โ‰ค 2 x ULN โ€ข ALT โ‰ค 5 x ULN * AST โ‰ค 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.
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What it tests

  • Gemcitabine 1000 mg
  • nab-paclitaxel
  • Stereotactic Body Radiation Therapy
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Where

1 site
Loma Linda University Health
Loma Linda, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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