NCT02528942

Brief Summary

The proposed study is in the field of thoracic radiation oncology where radiation therapy is used to treat lung cancer. The primary objective of the early phase clinical trial will be to evaluate the safety of performing functional avoidance radiation therapy for lung cancer patients using 4D computed tomography (4DCT) ventilation imaging.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

2 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

August 6, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 19, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

April 22, 2016

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2021

Completed
6 months until next milestone

Results Posted

Study results publicly available

July 22, 2021

Completed
Last Updated

July 22, 2021

Status Verified

July 1, 2021

Enrollment Period

4.8 years

First QC Date

August 6, 2015

Results QC Date

June 3, 2021

Last Update Submit

July 21, 2021

Conditions

Lung NeoplasmsLung Cancer

Keywords

Lung cancerRadiation therapy4DCT-ventilation imaging

Outcome Measures

Primary Outcomes (1)

  • Radiation Safety (Rate of Grade 2 or Higher (Grade 2+) Radiation Pneumonitis as Defined by the Common Toxicity Criteria for Adverse Effects (CTCAE) Scoring System

    To assess safety, investigators will evaluate the rate of grade 2 or higher (grade 2+) radiation pneumonitis as defined by the Common Toxicity Criteria for Adverse Effects (CTCAE) scoring system.

    Up to 14 months

Secondary Outcomes (1)

  • Percentage of Patients Eligible for 4DCT-ventilation Functional Avoidance

    Up to 14 months

Study Arms (1)

Radiation therapy

EXPERIMENTAL

The functional avoidance radiation therapy plan will be delivered using a standard course of radiation treatment on a linear accelerator. Patients will receive daily radiation treatment for 15-35 days.

Radiation: Radiation therapy

Interventions

Radiation therapyRADIATION

Radiation therapy will be given to study patients.

Radiation therapy

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of pathologically confirmed lung cancer by tumor biopsy and/or fine-need aspiration
  • Lung Cancer patients that will undergo definitive radiation therapy defined as 45-75 Gy as part of standard of care for their disease
  • years of age or older
  • Signed informed consent
  • Planned curative intent chemotherapy, delivered concurrently or sequentially in combination with radiotherapy
  • The patient's 4DCT-ventilation image meets image heterogeneity criteria

You may not qualify if:

  • Patients receiving Stereotactic Body Radiation Therapy
  • Patient receiving palliative radiation therapy (defined as less than 45 Gy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

Beaumont Health System

Royal Oak, Michigan, 48085, United States

Location

Related Publications (2)

  • Poiset SJ, Lombardo J, Castillo E, Castillo R, Jones B, Miften M, Kavanagh B, Dicker AP, Boyle C, Simone NL, Movsas B, Grills I, Rusthoven CG, Vinogradskiy Y, Wilson L. Patient-Reported Outcomes: Comparing Functional Avoidance and Standard Thoracic Radiation Therapy in Lung Cancer. JCO Clin Cancer Inform. 2025 Feb;9:e2400202. doi: 10.1200/CCI-24-00202. Epub 2025 Feb 4.

    PMID: 39903899DERIVED

  • Porter EM, Myziuk NK, Quinn TJ, Lozano D, Peterson AB, Quach DM, Siddiqui ZA, Guerrero TM. Synthetic pulmonary perfusion images from 4DCT for functional avoidance using deep learning. Phys Med Biol. 2021 Aug 23;66(17). doi: 10.1088/1361-6560/ac16ec.

    PMID: 34293726DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

Title
Yevgeniy Vinogradskiy PhD
Organization
Thomas Jefferson University
yevgeniy.vinogradskiy@Jefferson.edu
2159553605

Study Officials

  • Yevgeniy Vinogradskiy, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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

August 6, 2015

First Posted

August 19, 2015

Study Start

April 22, 2016

Primary Completion

January 25, 2021

Study Completion

January 25, 2021

Last Updated

July 22, 2021

Results First Posted

July 22, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

US(2)