mFOLFIRINOX With or Without Stereotactic Body Radiotherapy in Locally Advanced Pancreatic Adenocarcinoma

Randomized Phase 2 Study of mFOLFIRINOX With or Without Stereotactic Body Radiotherapy in Patients With Locally Advanced Pancreatic Adenocarcinoma

Modified FOLFIRINOX (mFOLFIRINOX) is the standard of care for patients with locally advanced pancreatic adenocarcinoma. While radiotherapy has been investigated for the management of resectable or locally advanced pancreatic adenocarcinoma, its role in the era of modern chemotherapy is not clear. Stereotactic body radiotherapy (SBRT) is the novel technique of radiotherapy to enhance the dose of radiotherapy to the target tumor lesion. This trial aims to compare the efficacy and safety of mFOLFIRINOX with or without SBRT in patients with locally advanced pancreatic adenocarcinoma

Inclusion Criteria:

• Informed consent
• Age 19 years or greater
• Cytologically or histologically confirmed pancreatic adenocarcinoma
• Locally advanced unresectable disease per National Comprehensive Cancer Network resectability criteria
• No active infection except chronic hepatitis on anti-viral therapy
• Eastern Cooperative Oncology Group performance status 0 or 1
• Body weight > 30 kg
• Normal organ and bone marrow function

Exclusion Criteria:

• Gastrointestinal obstruction
• Active gastrointestinal bleeding or ulcer
• Clinically significant cardiac disease or myocardial infarction within 6 months before the randomization
• Histology other than adenocarcinoma (adenosquamous or neuroendocrine tumors)
• Pregnancy or breastfeeding