Testing the Feasibility of a Simplified Workflow for Lung Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-28

Study Completion Date

2022-05-02

Brief Summary

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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.

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Detailed Description

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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

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Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Radiology Treatment Planning/Review

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.

Group Type OTHER

CT Simulation

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No