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Testing the Feasibility of a Simplified Workflow for Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04844736
Recruitment Status : Completed
First Posted : April 14, 2021
Last Update Posted : July 6, 2022
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Procedure: CT Simulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study: Testing the Feasibility of a Simplified Workflow for Lung Cancer Radiation Target Review With Radiology
Actual Study Start Date : May 28, 2021
Actual Primary Completion Date : February 24, 2022
Actual Study Completion Date : May 2, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer X-Rays

Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. Number of Completed Radiation Treatment Plans Reviewed [ Time Frame: Within four days after CT simulation ]
    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.


Secondary Outcome Measures :
  1. Number of Patients Whose Radiation Treatment Plans Changed [ Time Frame: 4 days ]
    Will be calculated using summary statistics including count (frequency) and corresponding 95% confidence intervals.

  2. Changes in Volumes After Radiation Treatment Changes - Gross Tumor Volume [ Time Frame: 4 days ]
    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.

  3. Changes in Volumes After Radiation Treatment Changes - Clinical Tumor Volume [ Time Frame: 4 days ]
    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. Changes in Volumes After Radiation Treatment Changes - Planning Tumor Volume [ Time Frame: 4 days ]
    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.

  5. Changes in Dose Delivered After Radiation Treatment Changes to the Lungs [ Time Frame: 4 days ]
    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).

  6. Changes in Dose Delivered After Radiation Treatment Changes to the Esophagus [ Time Frame: 4 days ]
    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).

  7. Number of Patients Who's Treatment Starts are Delayed [ Time Frame: 4 days ]
    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)

  8. Number of Changes Recommended by the Radiation Therapy Quality Assurance Conference (RT QAC) [ Time Frame: 4 days ]
    Will be calculated using summary statistics including count (frequency) and will also be captured in full qualitative form.

  9. Number of Patients with Acute Esophagitis [ Time Frame: 4 weeks after completion of therapy ]
    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.")

  10. Cancer Response [ Time Frame: 1 month after completion of therapy ]
    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.").



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04844736


Locations
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United States, North Carolina
High Point Medical Center
High Point, North Carolina, United States, 27262
Wake Forest Baptist Health - Lexington
Lexington, North Carolina, United States, 27292
Iredell Memorial Hospital
Statesville, North Carolina, United States, 28677
Wake Forest Baptist Health Sciences
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Michael Farris, MD Wake Forest Baptist Comprehensive Cancer Center
  Study Documents (Full-Text)

Documents provided by Wake Forest University Health Sciences:
Informed Consent Form  [PDF] September 21, 2021

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT04844736    
Other Study ID Numbers: IRB00072886
WFBCCC 01221 ( Other Identifier: Wake Forest Baptist Comprehensive Cancer Center )
First Posted: April 14, 2021    Key Record Dates
Last Update Posted: July 6, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases