This phase I trial studies the side effects of stereotactic body radiation therapy after induction chemotherapy in treating patients with pancreatic cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced). Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving chemotherapy before radiation therapy may kill more tumor cells.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02643498.
PRIMARY OBJECTIVE:
I. To identify the maximum tolerated dose (MTD) of stereotactic body radiotherapy (stereotactic body radiation therapy [SBRT]) in locally advanced pancreatic cancer (LAPC) patients who have not developed distant progression after following induction chemotherapy (leucovorin calcium, fluorouracil, irinotecan hydrochloride, and oxaliplatin [FOLFIRINOX] or gemcitabine [gemcitabine hydrochloride] and nab-paclitaxel [paclitaxel albumin-stabilized nanoparticle formulation] as per standard of care).
SECONDARY OBJECTIVES:
I. To preliminarily assess the 2 year local control, progression free and overall survival rates for locally advanced pancreatic cancer (LAPC) patients after induction chemotherapy and stereotactic body radiation therapy (SBRT).
II. To identify early changes in the normal small intestine after SBRT for LAPC using diffusion weighted imaging (DWI)-magnetic resonance imaging (MRI) and dynamic contrast-enhanced (DCE)-MRI derived parameters to document changes in tissue perfusion kinetics and heterogeneity that predict for development of gastrointestinal toxicity such as duodenal ulcers, strictures, or enteritis. (Cohorts 1-3)
III. To investigate vascular and cellular changes resulting from SBRT for LAPC using DWI-MRI and DCE-MRI derived parameters that can predict treatment response and to assess any correlation between these DWI-MRI and DCE-MRI derived parameters and local control and progression-free survival. (Cohorts 1-3)
IV. Evaluate quality of life (QOL) in terms of global QOL, physical symptoms, physical functioning and emotional well-being after induction chemotherapy and SBRT.
V. To prospectively evaluate the feasibility of obtaining adequate cytology samples for next generation sequencing. (Cohorts 1-3)
OUTLINE: This is a dose-escalation study of SBRT.
Beginning at least 2-4 weeks after completion of standard care induction chemotherapy comprising FOLFIRINOX or gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation, patients undergo a total of 3-15 fractions of SBRT administered every other day in the absence of disease progression or unacceptable toxicity. Patients also undergo DWI-MRI and DCE-MRI at baseline, within 90 minutes of the first fraction of SBRT, and at 6 weeks post-SBRT.
After completion of study treatment, patients are followed up at 6 weeks, 10-12 weeks, 6 months, 9 months, 12 months, and then every 6 months for years 2-5.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorMarsha Reyngold