Toward High Fidelity Adaptive Radiotherapy in the Thorax

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

Toward High Fidelity Adaptive Radiotherapy in the Thorax

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04731571
• Other study ID #: HighFidelityART
• Status: Not yet recruiting
• Start date: January 1, 2025
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 185
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed non-small cell lung cancer patients

• Locally advanced

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Radiation:
• CBCT-guided Adaptive Radiotherapy
The aim is to deliver adaptive radiotherapy using a CBCT-based radiotherapy delivery system.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the incidence of dose limiting toxicity (grade >= 3) for NSCLC patients using CBCT-guided adaptive radiotherapy and the CTCAE/QUANTEC protocols	The study aims to determine whether CBCT-guided adaptive radiotherapy can have a positive benefit in reducing the incidence of normal tissue toxicity (e.g. radiation pneumonitis)	2 years
Secondary	Quality of Life measures using the FACT-TOI Lung	Dose and volume data will be collected and correlated with treatment-related side effects and quality of life data.	2 years