Toward High Fidelity Adaptive Radiotherapy in the Thorax

Sponsor
Henry Ford Health System (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04731571
Collaborator
(none)
185
24

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: CBCT-guided Adaptive Radiotherapy

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 Design

Study Type:
Observational
Anticipated Enrollment :
185 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
Toward High Fidelity Adaptive Radiotherapy in the Thorax
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Adaptive Radiotherapy

Patients treated using adaptive radiotherapy on the Varian Ethos linear accelerator

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

Conventional Radiotherapy

Patients treated using conventional, non-adaptive radiotherapy on the Varian Truebeam linear accelerator

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Histologically confirmed non-small cell lung cancer patients

  • Locally advanced

Exclusion Criteria:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Henry Ford Health System

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Joshua Kim, Medical Physicist, Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT04731571
Other Study ID Numbers:
  • HighFidelityART
First Posted:
Feb 1, 2021
Last Update Posted:
Feb 1, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 1, 2021