Testing the Feasibility of a Simplified Workflow for Lung Cancer

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04844736
• Other study ID #: IRB00072886
• Secondary ID: WFBCCC 01221
• Status: Completed
• Phase: N/A
• Start date: May 28, 2021
• Est. completion date: May 2, 2022

Study information

• Verified date: April 2022
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: May 2, 2022
• Est. primary completion date: February 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Disease that is being treated as locally advanced non-small cell lung cancer (NSCLC) or limited stage small cell lung cancer (SCLC). Specifically, AJCC 8th edition staging with T3 or T4 and/or N1-3 disease. Patients with unclear pathology who are being treated clinically as non-small cell lung cancer or as limited stage small cell lung cancer are eligible.

• Plan for radiotherapy to be delivered with curative intent per the treating radiation oncologist in the Wake Forest Baptist Comprehensive Cancer Center Department of Radiation Oncology.

Exclusion Criteria: Not being treated with radiation, or being treated with non-curative intent per the treating radiation oncologist.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Completed Radiation Treatment Plans Reviewed	Completed initial radiology review within 4 business days after the date of CT simulation will be calculated using summary statistics including count (frequency) using a 95% confidence interval.	Within four days after CT simulation
Secondary	Number of Patients Whose Radiation Treatment Plans Changed	Will be calculated using summary statistics including count (frequency) and corresponding 95% confidence intervals.	4 days
Secondary	Changes in Volumes After Radiation Treatment Changes - Gross Tumor Volume	For patients whose radiation therapy plans are changed, the change in volume (in centimeters cubed) of gross tumor volume (GVT) before and after the recommended change is made will be summarized using mean and standard deviation and median range.	4 days
Secondary	Changes in Volumes After Radiation Treatment Changes - Clinical Tumor Volume	For patients whose radiation therapy plans are changed, the change in volume (in centimeters cubed) of clinical target volume (CTV) before and after the recommended change is made will be summarized using mean and standard deviation and median range.	4 days
Secondary	Changes in Volumes After Radiation Treatment Changes - Planning Tumor Volume	For patients whose radiation therapy plans are changed, the change in volume (in centimeters cubed) of planning target volume (PTV) before and after the recommended change is made will be summarized using mean and standard deviation and median range.	4 days
Secondary	Changes in Dose Delivered After Radiation Treatment Changes to the Lungs	For patients whose RT plans are changed, the change in the dose delivered to the lungs (V5, V10, V20) will be summarized using mean (standard deviation) and median (range).	4 days
Secondary	Changes in Dose Delivered After Radiation Treatment Changes to the Esophagus	For patients whose RT plans are changed, the change in the dose delivered to the and esophagus (mean, V60) will be summarized using mean (standard deviation) and median (range).	4 days
Secondary	Number of Patients Who's Treatment Starts are Delayed	For patients whose radiation therapy plans are changed: the proportion of treatment starts that are delayed from the initial planned start day due to the application of recommended changes will be calculated using summary statistics including count (frequency)	4 days
Secondary	Number of Changes Recommended by the Radiation Therapy Quality Assurance Conference (RT QAC)	Will be calculated using summary statistics including count (frequency) and will also be captured in full qualitative form.	4 days
Secondary	Number of Patients with Acute Esophagitis	Will be reported using descriptive statistics (mean, median, standard deviations, proportions, and 95% confidence intervals) and will also be compared to the historical institutional control incidence and severity of esophagitis using 1-sample z-tests and 1-sample tests of proportions (considering historical control as "population parameter.")	4 weeks after completion of therapy
Secondary	Cancer Response	Will be assessed by radiology on imaging and will be summarized using frequencies and proportions. Proportion of those with positive response will be compared to historical institution control using a 1-sample test of proportions (considering historical control as "population parameter.").	1 month after completion of therapy