Testing the Feasibility of a Simplified Workflow for Lung Cancer

Wake Forest University (WFU)

Status: Completed

Conditions: Lung Cancer

Treatments: Procedure: CT Simulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04844736

WFBCCC 01221 (Other Identifier)

IRB00072886

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Radiology Treatment Planning/Review

Other group

Description:

After patient consultation and enrollment, the patient will undergo routine CT simulation to initiate the radiation treatment planning process. The treating physician will contour the gross tumor volume (GTV) including the involved primary lung tumor and/or the involved lymph nodes. If the initial radiology review reflects concern for inadequate target volume delineation, the case will be flagged for multidisciplinary discussion between the radiation oncologist and radiologist.

Treatment:

Procedure: CT Simulation