This early phase I trial studies how well combination chemotherapy and radiation therapy before surgery works in treating patients with pancreatic cancer. Drugs used in chemotherapy, such as leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving combination chemotherapy and radiation therapy before surgery may make the tumor smaller, prevent the early spread of disease, and reduce the amount of normal tissue that needs to be removed.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01992705.
PRIMARY OBJECTIVES:
I. To determine the rate of downstaging to resectability in patients with borderline resectable pancreatic cancer receiving FOLFIRINOX (leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin) and stereotactic body radiation therapy (SBRT) (stereotactic radiosurgery) as preoperative therapy.
SECONDARY OBJECTIVES:
I. To assess the disease-free-survival, overall survival, time to recurrence and site of recurrence in patients with borderline resectable pancreatic cancer receiving preoperative FOLFIRINOX followed by SBRT.
II. To investigate the safety and tolerability of FOLFIRINOX and SBRT in patients with resectable pancreatic cancer.
III. To determine the radiologic and pathological response associated with preoperative SBRT and FOLFIRINOX therapy.
IV. To assess quality of life through and after treatment using the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire.
OUTLINE:
NEOADJUVANT CHEMOTHERAPY: Patients receive oxaliplatin intravenously (IV) over 2 hours, irinotecan hydrochloride IV over 90 minutes, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46-48 hours on day 1. Treatment repeats every 14 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
RADIATION THERAPY: Within 3 weeks of completing chemotherapy, patients undergo stereotactic radiosurgery once a day for 5 fractions separated by at least 48 hours.
SURGERY: Patients undergo pancreaticoduodenectomy within 4-10 weeks of completing radiation therapy (at the discretion of the operating surgeon).
After completion of study treatment, patients are followed up every 4 months for 3 years.
Lead OrganizationUniversity of Maryland/Greenebaum Cancer Center
Principal InvestigatorNavesh K Sharma
