Toward High Fidelity Adaptive Radiotherapy in the Thorax

Not yet recruiting

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Radiation: CBCT-guided Adaptive Radiotherapy

• Registration Number: NCT04731571
• Lead Sponsor: Henry Ford Health System

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.

Study Timeline

• Study First Submitted: 2021-01-26
• Study First Submitted QC: 2021-01-26
• Study First Posted: 2021-02-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23
• Study Start: 2025-01-01
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 185

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adaptive Radiotherapy	CBCT-guided Adaptive Radiotherapy	Patients treated using adaptive radiotherapy on the Varian Ethos linear accelerator

Primary Outcome Measures

Name	Time	Method
Determine the incidence of dose limiting toxicity (grade >= 3) for NSCLC patients using CBCT-guided adaptive radiotherapy and the CTCAE/QUANTEC protocols	2 years	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)

Secondary Outcome Measures

Name	Time	Method
Quality of Life measures using the FACT-TOI Lung	2 years	Dose and volume data will be collected and correlated with treatment-related side effects and quality of life data.