NCT04731571

Brief Summary

Daily adaptive radiotherapy with individualized planning margins for thoracic and pelvic cancer patients will increase the potential of reducing dose to OARs, thereby reducing treatment-related toxicities and ultimately providing these patients with a better quality of life. Thus, the overarching objective of this work is to develop a CBCT-guided adaptive workflow and to measure the benefits to patients of the adaptive treatment paradigm utilizing patient reported outcomes in a first-of-kind study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

January 26, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 1, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

February 5, 2021

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2025

Completed
Last Updated

June 11, 2025

Status Verified

June 1, 2025

Enrollment Period

3.7 years

First QC Date

January 26, 2021

Last Update Submit

June 6, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • The number of patients with treatment-related Grade 3 or higher adverse cardiac events as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v5.0) at 2 years

    A set of treatment planning strategies were designed and retrospectively implemented for locally advanced, non-small cell lung cancer (NSCLC) patients.

    through study completion, an average of 2 years

Study Arms (1)

Radiotherapy

Patients with locally advanced non-small cell lung cancer previously treated with definitive chemoradiotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with unresectable, locally advanced non-small cell lung cancer

You may qualify if:

  • Histologically confirmed non-small cell lung cancer patients
  • Locally advanced

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Health

Detroit, Michigan, 48202, United States

Location

Related Publications (5)

  • Kim JP, Dewalt J, Feldman A, Adil K, Movsas B, Chetty IJ. Feasibility of radical cardiac-sparing, treatment planning strategies for patients with locally advanced, non-small cell lung cancer. J Appl Clin Med Phys. 2022 Dec;23(12):e13784. doi: 10.1002/acm2.13784. Epub 2022 Oct 13.

    PMID: 36237114BACKGROUND
  • Yan D, Georg D. Adaptive radiation therapy. Z Med Phys. 2018 Aug;28(3):173-174. doi: 10.1016/j.zemedi.2018.03.001. Epub 2018 Mar 27. No abstract available.

    PMID: 29602589BACKGROUND
  • Zhong H, Siddiqui SM, Movsas B, Chetty IJ. Evaluation of adaptive treatment planning for patients with non-small cell lung cancer. Phys Med Biol. 2017 Jun 7;62(11):4346-4360. doi: 10.1088/1361-6560/aa586f. Epub 2017 Jan 10.

    PMID: 28072395BACKGROUND
  • Herschtal A, Te Marvelde L, Mengersen K, Foroudi F, Eade T, Pham D, Caine H, Kron T. Sparing healthy tissue and increasing tumor dose using bayesian modeling of geometric uncertainties for planning target volume personalization. Int J Radiat Oncol Biol Phys. 2015 Jun 1;92(2):446-52. doi: 10.1016/j.ijrobp.2015.01.034. Epub 2015 Apr 3.

    PMID: 25847606BACKGROUND
  • Dial C, Weiss E, Siebers JV, Hugo GD. Benefits of adaptive radiation therapy in lung cancer as a function of replanning frequency. Med Phys. 2016 Apr;43(4):1787. doi: 10.1118/1.4943564.

    PMID: 27036576BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Physicist

Study Record Dates

First Submitted

January 26, 2021

First Posted

February 1, 2021

Study Start

February 5, 2021

Primary Completion

October 22, 2024

Study Completion

February 27, 2025

Last Updated

June 11, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations