This phase II trial studies the effectiveness and safety of adding local ablative therapy to usual treatment in treating patients with gastrointestinal cancers that have spread to only a few locations (oligo-progressive). Local ablative therapy includes stereotactic ablative body radiotherapy (SABR), hypofractionated radiation therapy, or interventional radiology (IR) ablation therapy. SABR is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. 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. Adding local ablative therapy to the usual treatment may work better than the usual treatment alone in treating oligo-progressive gastrointestinal cancers.
Additional locations may be listed on ClinicalTrials.gov for NCT06101277.
Locations matching your search criteria
United States
California
Chico
Enloe Medical CenterStatus: Active
Contact: Jonathan Edgar Clark
Phone: 530-332-7300
Marysville
Fremont - Rideout Cancer CenterStatus: Active
Contact: Ky Nam Bao Nguyen
Sacramento
University of California Davis Comprehensive Cancer CenterStatus: Active
Contact: Edward J. Kim
Phone: 916-734-3772
Truckee
Gene Upshaw Memorial Tahoe Forest Cancer CenterStatus: Active
Contact: Thomas John Semrad
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 SBAR 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 during screening and on study.
Upon 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
