This phase II trial tests the effectiveness and safety of local ablative therapy in treating patients undergoing systemic therapy for disease progression at a limited number of sites (oligoprogression) with either stereotactic ablative body radiotherapy (SABR), hypofractionated radiation therapy, or interventional radiology (IR) ablation therapy. SABR is a high dose of radiation delivered to all the current cancer spots with the goal to prevent these spots from growing, while limiting the dose to the surrounding organs. Hypofractionated radiation is a type of treatment in which the total dose of radiation is divided into large doses and treatments are given less than once a day. IR ablation therapy, such as radiofrequency ablation, uses a high frequency, electric current to kill tumor cells. IR ablation therapy, such as microwave ablation, kills tumor cells by heating them to several degrees above normal body temperature. Information gained from this trial may allow researchers to determine the clinical benefit of adding local ablative therapy to systemic therapy in treating patients with oligoprogression.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06103682.
Locations matching your search criteria
United States
California
Marysville
Fremont - Rideout Cancer CenterStatus: Active
Contact: Ky Nam Bao Nguyen
Phone: 530-749-4400
Sacramento
University of California Davis Comprehensive Cancer CenterStatus: Active
Contact: Edward J. Kim
Phone: 916-734-5810
Truckee
Gene Upshaw Memorial Tahoe Forest Cancer CenterStatus: Active
Contact: Thomas John Semrad
Phone: 530-582-6450
PRIMARY OBJECTIVE:
I. To evaluate the efficacy of adding locally ablative therapies to systemic treatment regimens in patients with oligo-progressive solid tumors.
SECONDARY OBJECTIVES:
I. To evaluate the toxicities attributable to adding locally ablative therapies to systemic treatment regimens in patients with oligo-progressive solid tumors.
II. To further evaluate the efficacy of adding locally ablative therapies to systemic treatment regimens in patients with oligo-progressive solid tumors.
EXPLORATORY OBJECTIVE:
I. To further evaluate the efficacy of adding locally ablative therapies to systemic treatment regimens in patients with oligo-progressive solid tumors.
OUTLINE:
Patients on systemic therapy undergo local ablative therapy to up to 5 oligoprogression sites with either SABR or hypofractionated radiation over 1-15 fractions or IR ablation therapy per discretion of treating provider on trial. Treatment continues for up to 2 months in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) and/or ultrasound imaging on study.
After completion of study treatment, patients are followed up to 2 weeks, and then at months 3, 6, 9, 12, and 18, year 2, and up to 5 years.
Lead OrganizationUniversity of California Davis Comprehensive Cancer Center
Principal InvestigatorEdward J. Kim
