This pilot trial studies fludeoxyglucose F 18–positron emission tomography (FDG-PET) and ventilation/perfusion single photon emission computed tomography (V/Q SPECT), before treatment and then again during radiation therapy in treating patients with stage IIA-IIIB non-small cell lung cancer (NSCLC) that cannot be removed by surgery. Diagnostic procedures, such as FDG-PET, uses small amounts of radioactive glucose (FDG) to make images of the whole body and areas of active cancer. V/Q SPECT is an image mapping tool that helps find out how well the lungs are working and where the cancer or healthy lung is located. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Imaging studies such as FDG-PET and V/Q SPECT may help researchers design radiation treatment plans that help decrease the amount of toxicity patients have from this type of treatment and provide the best treatment.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02492867.
PRIMARY OBJECTIVES:
I. Establish the feasibility of the proposed adaptive treatment strategy.
II. To obtain preliminary estimates of the toxicity of and doses achievable by the proposed response-driven adaptive treatment strategy in patients with stage II/III NSCLC.
SECONDARY OBJECTIVES:
I. To obtain preliminary estimates of local regional tumor control from an adaptive approach, which will aid in the design of a subsequent randomized phase II trial.
II. To determine the residual uncertainties in V/Q SPECT scans related to the accuracy with which persistent tumor subvolumes and the spatial distribution of local function of uninvolved lung could be mapped to guide plan modification.
III. To determine the time to local regional progression and death in patients treated with this response-driven adaptive regimen.
IV. To refine our biophysical normal tissue complication probability (NTCP) model to individualize and adapt radiation dose prescription to minimize lung injury.
OUTLINE:
RADIATION THERAPY, FDG-PET-CT, AND V/Q SPECT: Patients undergo radiation therapy once daily (QD) 5 days per week for 30 treatments. Within 2 weeks prior to or after treatment planning CT and after completion of two-thirds of radiation therapy, patients undergo FDG-PET-CT and V/Q SPECT.
CONCURRENT CHEMOTHERAPY: Some patients also receive paclitaxel intravenously (IV) over 60-90 minutes and carboplatin IV over 30-60 minutes once weekly for 6 weeks.
CONSOLIDATION CHEMOTHERAPY OR IMMUNOTHERAPY: Approximately 4-6 weeks after completion of radiation therapy when esophagitis and chemo-induced neuropathy are grade 1 or less, and absolute neutrophil count (ANC) > 1500 and platelet count > 100,000, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Stage III patients who have not progressed following chemoradiation may receive durvalumab IV over 1 hour on day 1. Treatment repeats every 14 days for up to 26 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study, patients are followed up at 3, 6, 9, 12, 18, 24, 30, and 36 months.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationUniversity of Michigan Rogel Cancer Center
Principal InvestigatorShruti Jolly
