Toward High Fidelity Adaptive Radiotherapy in the Thorax

NCT ID: NCT04731571

Last Updated: 2025-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-05

Study Completion Date

2025-02-27

Brief Summary

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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.

Detailed Description

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1. To individualize the planning margins used for treatment, we will assess the impact of the different uncertainties on patient-specific planning margins. We determine the dosimetric uncertainties for patients during planning and delivery through the daily adaptive process. In so doing, we will determine the relationship between the dose distributions and the associated treatment outcomes.
2. To perform retrospective clinical studies using patient data, we determine the relationship between dosimetry from plans developed using the optimized patient-specific margins (plans from (1) that are robust to uncertainties) and retrospective, clinical outcomes. This data will be used to inform daily adaptation and plan quality criteria for a prospective clinical protocol.
3. To develop (with our clinical collaborators) a first-of-kind study to measure the efficacy of daily adaptive treatment with individualized planning margins, using clinical and quality of life (patient reported) outcomes, and to compare these against the conventional treatment approach, where a single treatment plan with population-based treatment margins is utilized for all treatment fractions.

Conditions

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Carcinoma, Non-Small-Cell Lung

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Radiotherapy

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed non-small cell lung cancer patients
* Locally advanced
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Henry Ford Health System

OTHER

Sponsor Role lead

Responsible Party

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Joshua Kim

Medical Physicist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Henry Ford Health

Detroit, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 36237114 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29602589 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28072395 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25847606 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27036576 (View on PubMed)

Other Identifiers

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HighFidelityART

Identifier Type: -

Identifier Source: org_study_id

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