NCT04844736

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable lung-cancer

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable lung-cancer

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 14, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

May 28, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2022

Completed
Last Updated

July 6, 2022

Status Verified

April 1, 2022

Enrollment Period

9 months

First QC Date

April 12, 2021

Last Update Submit

June 30, 2022

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (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.

    Within four days after CT simulation

Secondary Outcomes (10)

  • Number of Patients Whose Radiation Treatment Plans Changed

    4 days

  • Changes in Volumes After Radiation Treatment Changes - Gross Tumor Volume

    4 days

  • Changes in Volumes After Radiation Treatment Changes - Clinical Tumor Volume

    4 days

  • Changes in Volumes After Radiation Treatment Changes - Planning Tumor Volume

    4 days

  • Changes in Dose Delivered After Radiation Treatment Changes to the Lungs

    4 days

  • +5 more secondary outcomes

Study Arms (1)

Radiology Treatment Planning/Review

OTHER

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

Interventions

CT SimulationPROCEDURE

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.

Radiology Treatment Planning/Review

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

High Point Medical Center

High Point, North Carolina, 27262, United States

Location

Wake Forest Baptist Health - Lexington

Lexington, North Carolina, 27292, United States

Location

Iredell Memorial Hospital

Statesville, North Carolina, 28677, United States

Location

Wake Forest Baptist Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (1)

  • 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.

    PMID: 36759296DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Michael Farris, MD

    Wake Forest Baptist Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2021

First Posted

April 14, 2021

Study Start

May 28, 2021

Primary Completion

February 24, 2022

Study Completion

May 2, 2022

Last Updated

July 6, 2022

Record last verified: 2022-04

Locations

US(4)