This clinical trial investigates whether adding an additional doctor (called a radiologist) to the process of designing a radiation plan for the treatment of lung cancer that is large and/or has spread to lymph nodes (locally advanced), will help increase the accuracy of mapping out cancer from the surrounding normal organs. A radiation oncologist is a doctor who delivers radiation treatments to tumors in order to kill cancer cells. Radiologists can help radiation oncologist understand exactly where the tumor targets are located on scans. Sometimes, it is difficult to see the difference between tumor and nearby organs (like the swallowing tube) especially when these are touching one another. If a patients has cancer in the lymph nodes in the middle of the check, it can also be difficult to determine which lymph nodes are involved or not involved with cancer. The radiation oncologist depends upon radiology reports to help guide decisions for what to treat. This trial tests a more efficient way to share radiation plans with the radiology team so that they can review the plans and provide real time feedback before treatment is delivered. This review and feedback process for lung cancer radiation planning may help improve patient safety and the quality of cancer treatments.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04844736.
PRIMARY OBJECTIVE:
I. To demonstrate the feasibility of radiology completing real time review of radiation oncology treatment plans within 4 business days of the date of computed tomography (CT) simulation (defined as day = 0).
SECONDARY OBJECTIVES:
I. To estimate the proportion of patients whose radiation therapy (RT) plans are changed as a result this workflow.
II. For patients whose RT plans are changed as a result this workflow, determine the absolute and percentage volume changes in the gross tumor volume, clinical target volume and planning target volume as a result of these changes implemented.
III. For patients whose RT plans are changed as a result of this workflow: determine if recommended changes in the gross target volume (GTV) resulted in improved dosimetry to surrounding normal structures.
IIIa. Specifically, determine the absolute and percentage changes in the dose delivered to the lungs (V5, V10, V20) and esophagus (mean, V60) as a result of changes in the GTV.
IV. For patients whose RT plans are changed as a result of this workflow, determine if changes led to treatment delays from their standard planned start date.
V. For patients whose RT plans are changed as a result of this workflow, to describe the most common types of changes recommended (i.e. modification of parenchymal lung volumes, missing involved lymph nodes, covering too much normal tissue in the GTV).
VI. Determine whether acute esophagitis incidence changed in our entire sample as a result of this review during treatment and within 4 weeks following treatment, compared to institutional historical control databases of patients treated without formal radiology review.
VII. Determine whether tumor response at 4 weeks post treatment differs in our entire sample compared to institutional historical control databases of patients treated without formal radiology review.
VIII. Assess effects of the workflow intervention on the radiologists and radiation oncologists who participate in the study, with respect to their work practices and barriers/ uncertainty faced in the creation, and follow up of radiation treatment plans.
OUTLINE:
Patients undergo CT simulation for radiation therapy planning per standard of care.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationWake Forest University Health Sciences
Principal InvestigatorMichael K. Farris
