AzTrials
AzTrials

Lung CancerNCT04844736

Testing the Feasibility of a Simplified Workflow for Lung Cancer

A study testing CT Simulation in people with Lung Cancer, run by Wake Forest University Health Sciences at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
CT Simulation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
4 sitesUnited States
Study dates
28 May 2021to 2 May 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

None listed.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • High Point Medical Center

    High Point, North Carolina, 27262

  • Wake Forest Baptist Health - Lexington

    Lexington, North Carolina, 27292

  • Iredell Memorial Hospital

    Statesville, North Carolina, 28677

  • Wake Forest Baptist Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

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

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.

Read the 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.
Conditions
Lung Cancer
Being tested
CT Simulation
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CT SimulationProcedure or surgery

    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.

Study groups in NCT04844736
Study groupRoleWhat they receive
Radiology Treatment Planning/ReviewOtherAfter 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.
Receives: Procedure: CT Simulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Within four days after CT simulation

Secondary outcomes (10)

  1. Number of Patients Whose Radiation Treatment Plans Changed

    Will be calculated using summary statistics including count (frequency) and corresponding 95% confidence intervals.

    Measured: 4 days

  2. 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.

    Measured: 4 days

  3. 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.

    Measured: 4 days

  4. 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.

    Measured: 4 days

  5. 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).

    Measured: 4 days

  6. 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).

    Measured: 4 days

  7. 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)

    Measured: 4 days

  8. 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.

    Measured: 4 days

  9. 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.")

    Measured: 4 weeks after completion of therapy

  10. 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.").

    Measured: 1 month after completion of therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2021
  2. Study start28 May 2021
  3. Primary completion24 Feb 2022
  4. Study completion2 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04844736
Sponsor's protocol ID
IRB00072886
Other IDs
WFBCCC 01221
Status last verified
Apr 2022
First submitted
12 Apr 2021
Last updated
6 Jul 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Farris MK, Razavian NB, Hughes RT, Ververs JD, Snavely AC, Leyrer CM, Tye KE, Allen LF, Pacholke HD, Weaver KE, Bunch PM, Chan MD, Clark H, Puthoff G, Farris JC, Steber CR, Wentworth S, Levine BJ, Nightingale CL, Ponnatapura J. Bridging the Communication Gaps: A Prospective Single-Arm Pilot Study Testing the Feasibility of Interdisciplinary Radiotherapy Planning in Locally Advanced Lung Cancer. Acad Radiol. 2023 Nov;30(11):2566-2573. doi: 10.1016/j.acra.2023.01.019. Epub 2023 Feb 8.

    PubMed 36759296

Questions about this trial

What is this clinical trial studying?

A study testing CT Simulation in people with Lung Cancer, run by Wake Forest University Health Sciences at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Completed Radiation Treatment Plans Reviewed (time frame: Within four days after CT simulation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04844736, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in