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Spots Global Cancer Trial Database for Testing the Feasibility of a Simplified Workflow for Lung Cancer

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Trial Identification

Brief Title: Testing the Feasibility of a Simplified Workflow for Lung Cancer

Official Title: Pilot Study: Testing the Feasibility of a Simplified Workflow for Lung Cancer Radiation Target Review With Radiology

Study ID: NCT04844736

Conditions

Lung Cancer

Interventions

CT Simulation

Study Description

Brief Summary: The purpose of this research study is to see if adding an "extra" check by formal radiology review is possible without disrupting the normal processes that take place to develop and prepare a safe radiation treatment plan for patients.

Detailed Description: Primary Objectives: The primary objective will be to demonstrate the feasibility of radiology completing real time review of radiation oncology treatment plans within 4 business days of the date of CT simulation (defined as day = 0). If 50% of plans can be reviewed by any member of the thoracic radiology team (Includes radiology PI and co-investigators) and feedback is submitted to radiation oncology with Appendix D within 4 business days of the date of simulation, then we will consider this workflow feasible. Secondary Objectives: * Our primary secondary objective will be to estimate the proportion of patients whose RT plans are changed as a result this workflow. * For patients whose radiation therapy 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. * For patients whose radiation therapy plans are changed as a result of this workflow: determine if recommended changes in the gross tumor volume resulted in improved dosimetry to surrounding normal structures. 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 gross tumor volume. * For patients whose radiation therapy plans are changed as a result of this workflow, determine if changes led to treatment delays from their standard planned start date. * For patients whose radiation therapy 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 gross tumor volume). * 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. * 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

High Point Medical Center, High Point, North Carolina, United States

Wake Forest Baptist Health - Lexington, Lexington, North Carolina, United States

Iredell Memorial Hospital, Statesville, North Carolina, United States

Wake Forest Baptist Health Sciences, Winston-Salem, North Carolina, United States

Contact Details

Name: Michael Farris, MD

Affiliation: Wake Forest Baptist Comprehensive Cancer Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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