GCC 2545- Improving Post-Radiotherapy Respiratory Function Through Sparing Serial and Parallel Components in the Lung

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT07679607
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Lung Cancer (NSCLC)
  • Radiation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SOC Radiation Treatment Planning — RADIATION
    Two treatment plans will be created for each patient - an SOC RT plan and an INSPIRE RT plan. Both plans will fulfill clinical dosimetric objectives for tumor target and OARs, and will need to be reviewed and approved by the Radiation Oncologist. The trial will allow intensity modulated radiotherapy (IMRT) or volumetric modulated arc therapy (VMAT). Both techniques have been validated for INSPIRE RT previously. Both plans meet clinical dosimetric objectives. The INSPIRE plan achieves the additional goal of sparing functional units by better modulating the low dose and the intermediate dose compared to the SOC plan
  • INSPIRE Radiation Treatment Planning — RADIATION
    Two treatment plans will be created for each patient - an SOC RT plan and an INSPIRE RT plan. Both plans will fulfill clinical dosimetric objectives for tumor target and OARs, and will need to be reviewed and approved by the Radiation Oncologist. The trial will allow intensity modulated radiotherapy (IMRT) or volumetric modulated arc therapy (VMAT). Both techniques have been validated for INSPIRE RT previously. Both plans meet clinical dosimetric objectives. The INSPIRE plan achieves the additional goal of sparing functional units by better modulating the low dose and the intermediate dose compared to the SOC plan

Study Details

Decreased respiratory function is a common side effect experienced by non-small cell lung cancer (NSCLC) patients who receive radiation therapy. In current clinical practice when treating cancerous lesions in the lung, it is not standard to explicitly try and avoid excessive radiation dose and therefore radiation injury to smaller airways. However, because of this patients may obtain damage to an airway segment can cause downstream regions in the lung to lose their "supply line" and, therefore, cause patients to lose the ability to exchange oxygen with the blood. The purpose of this clinical trial is to systematically compare post-treatment lung function of those who receive regular clinical radiation therapy (standard of care \[SoC\]) versus those who receive the airway-sparing radiation therapy regimen. The investigators hope to show that, by preserving airways and connected lung regions, participants will be able to retain a larger amount of their lung function, which will have a direct, positive impact on their post-treatment quality of life.

Key Dates

Start date
Aug 31, 2026
Status verified
Jun 2026
Primary completion
Aug 31, 2028
Completion
Aug 31, 2030

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm 1- SOC Radiation Plan
    Standard RT Plan Creation
  • Experimental: Arm 2- INSPIRE Radiation Plan
    INSPIRE plan achieves the additional goal of sparing functional units by better modulating the low dose and the intermediate dose compared to the SOC plan.

Primary Outcome Measure

Measurement of Post-Radiation retention of ventilation at 12 months through imaging. [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Maryland Greenebaum Cancer CenterBaltimoreMaryland21201
Caitlin Eggleston, MPH
[email protected]
410-369-5351

Find similar trials in Baltimore, MD

By research site
University of Maryland Greenebaum Cancer Center· Baltimore, MD

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