NCT04844736

Testing the Feasibility of a Simplified Workflow for Lung Cancer

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
PROCEDURE	CT Simulation	Patient will undergo routine CT simulation to initiate radiation treatment planning process. For the purposes of this study, the day of CT simulation "mapping scan" will be counted as day 0. After the patient completes the CT simulation scan, the CT images and plan/structure files will be sent to the treatment planning system. The treating physician will contour the gross tumor volume (GTV) including the involved primary lung tumor and/or the involved lymph nodes.

Timeline

• Start date: 2021-05-28
• Primary completion: 2022-02-24
• Completion: 2022-05-02
• First posted: 2021-04-14
• Last updated: 2022-07-06

Locations

4 sites across 1 country: United States