This phase II trial studies the effect of standard of care chemotherapy with or without stereotactic body radiation therapy in treating patients with pancreatic cancer that has spread to a limited amount of places in the body (oligometastatic). Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with stereotactic body radiation therapy may help improve tumor control, decrease risk of tumor spreading more, decrease side effects, and prolong survival.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04975516.
PRIMARY OBJECTIVE:
I. Compare progression free survival (PFS) between stereotactic body radiation therapy (SBRT) + standard chemotherapy versus (vs.) standard chemotherapy alone in patients with oligometastatic pancreatic cancer.
SECONDARY OBJECTIVES:
I. Confirmed response rate.
II. Overall survival.
III. Adverse events.
IV. Longitudinal assessment of circulating tumor cells (CTC) and circulating tumor deoxyribonucleic acid (ctDNA).
CORRELATIVE RESEARCH OBJECTIVE:
I. To evaluate fatigue, and other patient-reported outcomes.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients undergo SBRT once daily (QD) or every other day for 5 fractions and receive chemotherapy per standard of care on study. Additionally, patients undergo computed tomography (CT), magnetic resonance imaging (MRI), and blood collection throughout the study.
GROUP II: Patients receive chemotherapy per standard of care on study. Additionally, patients undergo CT, MRI, and blood collection throughout the study. Patients who have local disease progression at known sites and no new sites of progression may crossover to the radiotherapy arm.
After completion of study treatment, patients are followed up at 7 and 14 days, and then every 8-12 weeks for 2 years.
Lead OrganizationMayo Clinic in Florida
Principal InvestigatorMichael Scott Rutenberg