Clinical trial NCT04844736: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2021-04-14
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Completed Radiation Treatment Plans Reviewed
timeFrame: Within four days after CT simulation
Secondary outcomes:
measure: Number of Patients Whose Radiation Treatment Plans Changed
timeFrame: 4 days
measure: Changes in Volumes After Radiation Treatment Changes - Gross Tumor Volume
timeFrame: 4 days
measure: Changes in Volumes After Radiation Treatment Changes - Clinical Tumor Volume
timeFrame: 4 days
measure: Changes in Volumes After Radiation Treatment Changes - Planning Tumor Volume
timeFrame: 4 days
measure: Changes in Dose Delivered After Radiation Treatment Changes to the Lungs
timeFrame: 4 days
measure: Changes in Dose Delivered After Radiation Treatment Changes to the Esophagus
timeFrame: 4 days
measure: Number of Patients Who's Treatment Starts are Delayed
timeFrame: 4 days
measure: Number of Changes Recommended by the Radiation Therapy Quality Assurance Conference (RT QAC)
timeFrame: 4 days
measure: Number of Patients with Acute Esophagitis
timeFrame: 4 weeks after completion of therapy
measure: Cancer Response
timeFrame: 1 month after completion of therapy
Other outcomes:
Locations:
city: High Point
country: United States
facility: High Point Medical Center
state: North Carolina
city: Lexington
country: United States
facility: Wake Forest Baptist Health - Lexington
state: North Carolina
city: Statesville
country: United States
facility: Iredell Memorial Hospital
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest Baptist Comprehensive Cancer Center
name: Michael Farris, MD
role: PRINCIPAL_INVESTIGATOR
References: