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Toward High Fidelity Adaptive Radiotherapy in the Thorax

Toward High Fidelity Adaptive Radiotherapy in the Thorax

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04731571
Enrollment
20
Registered
2021-02-01
Start date
2021-02-05
Completion date
2025-02-27
Last updated
2025-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Non-Small-Cell Lung

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.

Detailed description

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.

Interventions

None listed

Sponsors

Henry Ford Health System
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
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 yearsthrough study completion, an average of 2 yearsA set of treatment planning strategies were designed and retrospectively implemented for locally advanced, non-small cell lung cancer (NSCLC) patients.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026