Finding studies
Finding studies
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Lead
Roswell Park Cancer Institute
PRIMARY OBJECTIVE: I. Evaluate the impact of incorporating high isodoses termed "hot spots" in radiation therapy planning on local control. SECONDARY OBJECTIVES: I. Evaluate the impact of "hot spots" in radiation therapy planning on progression-free survival (PFS). II. Evaluate the impact of "hot spots" in radiation therapy planning on overall survival (OS). III. Evaluate the impact of tumor size on local control and if hotspot grouping impacts local control in a size-dependent manner. IV. To prospectively evaluate the PFS in early stage-non small cell lung cancer (ES-NSCLC) patients undergoing SABR who are already taking a beta-blocker as well as a potential interaction between beta-blocker usage and the perceived stress scale. V. Will evaluate for any potential interactions between quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer \[EORTC QLQ-LC13\]) and hotspot grouping. VI. Evaluate the impact of "hot spots" in radiation therapy planning on toxicity by total number of grade 3+ adverse effects. EXPLORATORY OBJECTIVE: I. Change in immune cell marker levels at week 12 post-SBRT (± 1 week) versus baseline, such as mediators of tumor antigen presentation, costimulatory molecules, immune effector cell populations, including CD4+ and CD+8 T-cells, T regulatory cells (CD4+CD25+FoxP3+), natural killer (NK) cells, monocytes, macrophages, dendritic cells (DCs) and myeloid derived suppressor cells (MDSCs). OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive standard of care (SOC) SBRT for 1-5 fractions over 1-11 days, in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) scan with or without positron emission tomography (PET) scan and blood sample collection throughout the study. Patients may undergo lymph node sampling throughout the study. ARM II: Patients receive hot spot SBRT for 1-5 fractions over 1-11 days, in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan with or without PET scan and blood sample collection throughout the study. Patients may undergo lymph node sampling throughout the study. After completion of study treatment, patients are followed up every 3 months for 1 year and then every 3-6 months up to month 36.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
