This phase II trial tests the safety of positron emission tomography (PET) guided stereotactic body radiation therapy (SBRT) and how well it works to treat non-small cell lung cancer (NSCLC), melanoma, and renal cell carcinoma (RCC) that has up to 5 sites of progression (oligoprogression) compared to standard SBRT. SBRT 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. A PET scan is an imaging test that looks at your tissues and organs using a small amount of a radioactive substance. It also checks for cancer and may help find cancer remaining in areas already treated. Using a PET scan for SBRT planning may help increase the dose of radiation given to the most resistant part of the cancer in patients with oligoprogressive NSCLC, melanoma, and RCC.
Additional locations may be listed on ClinicalTrials.gov for NCT05830058.
Locations matching your search criteria
United States
California
Duarte
City of Hope Comprehensive Cancer CenterStatus: Active
Contact: Arya Amini
Phone: 626-218-4589
Irvine
City of Hope at Irvine LennarStatus: Active
Contact: Arya Amini
PRIMARY OBJECTIVE:
I. PET adaptive SBRT is both feasible and safe and allows for a higher total dose of radiation through an inter-fraction simultaneous integrated boost (SIB) based on inter-fraction PET uptake, leading to improved local control outcomes compared to current standard SBRT planning without a SIB.
SECONDARY OBJECTIVES:
I. Determine the duration of local and distant control followed PET adaptive SBRT treatment compared to standard external beam radiation therapy (EBRT).
II. Evaluate the utility of measuring circulating tumor deoxyribonucleic acid (DNA) (ctDNA) before, during and after SBRT in conjunction with biological imaging to assess early disease response.
III. Identify genomic predictors to predict for distant progression.
IV. Determine durability of current systemic therapy with SBRT to oligoprogressive sites.
EXPLORATORY OBJECTIVES:
I. Biomarker changes based on ctDNA before, during and after treatment.
II. Changes in fludeoxyglucose (FDG) uptake with SBRT and combined checkpoint inhibitor and/or molecularly targeted therapeutics during and after treatment and correlation with local and distant control.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo 5 SBRT treatments every other day on study. Additionally, patients undergo computed tomography (CT) or PET/CT throughout study. Patients may also undergo blood collection throughout the study and may optionally undergo tissue biopsy at screening.
ARM II: Patients undergo 3 SBRT treatments every other day during week 1, undergo PET/CT and replanning one month post SBRT, then undergo 2 additional treatments with SIB on study. Additionally, patients undergo CT or PET/CT throughout study. Patients may also undergo blood collection throughout the study and may optionally undergo tissue biopsy at screening.
After completion of study treatment patients are followed up every 3 months until progression or up to 1 year.
Lead OrganizationCity of Hope Comprehensive Cancer Center
Principal InvestigatorArya Amini