A Phase II Trial of Pre-operative Chemotherapy (With Gemcitabine and Nab- Paclitaxel) and Stereotactic Body Radiotherapy Followed by Surgery and Chemotherapy in Patients With Resectable Pancreatic Adenocarcinoma

Trial ID: NCT03492671

Interventional - Phase 2 - Recruiting

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

• Pancreas Adenocarcinoma
• Resectable Pancreatic Cancer

Interventions

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

Eligibility

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.

Sponsor

Loma Linda University

Source: ClinicalTrials.gov

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