Comparisons of Different Neoadjuvant Chemotherapy Regimens With or Without Stereotactic Body Radiation Therapy for Borderline Resectable Pancreatic Cancer: Study Protocol of a Prospective, Randomized Phase II Trial

Trial ID: NCT03777462

Interventional - Phase 2 - Unknown status

This study is to investigate whether neoadjuvant chemotherapy plus SBRT results in better outcomes compared with neoadjuvant chemotherapy alone and also compare the efficacy of gemcitabine plus nab-paclitaxel with SBRT and S-1 plus nab-paclitaxel with SBRT.

Conditions

• Pancreatic Cancer

Interventions

• Neoadjuvant gemcitabine plus nab-paclitaxel
• Neoadjuvant gemcitabine plus nab-paclitaxel with SBRT
• Neoadjuvant S-1 plus nab-paclitaxel with SBRT

Eligibility

Inclusion criteria

• Age≥18 years old and ≤80 years old;
• Histological proven pancreatic adenocarcinoma;
• Borderline resectable pancreatic cancer proven by imaging examinations via multidisciplinary approaches according to NCCN guidelines;
• No prior chemotherapy or radiotherapy;
• ECOG of 0 or 1;
• Routine blood test: absolute neutrophil count\>1500/mm3, platelet\>100000/mm3;
• Normal liver function: serum total bilirubin≤2.0mg/dl, ALT and AST\<2.5 times of the upper limit of normal value;
• Normal kidney function: serum creatinine\<1.5 times of the upper limit of normal value or creatinine clearance rate\>45ml/min;
• No severe comorbidities.

Exclusion criteria

• Metastatic pancreatic cancer;
• Patients who had surgeries, chemotherapy or other treatments before inclusion;
• Impaired organ functions: heart failure (New York Heart Association III-IV), coronary heart disease, myocardial infarction within 6 months, severe cardiac arrhythmia and respiratory failure;
• Confirmed other cancer within 5 years;
• Pregnant women or lactating women;
• Patients enrolled in other clinical trials or incompliant of regular follow up;
• Patients who did not provide an informed consent.

Sponsor

Changhai Hospital

Source: ClinicalTrials.gov

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