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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Maryland, Baltimore

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Step 1- Inclusion Criteria

Adult (≥18 years) patients (both sexes) with histologically diagnosed Stage III NSCLC per AJCC ver 9

Patients to be treated with definitive external beam photon radiotherapy with or without systemic therapy (e.g., chemothrapy, immunotherapy).

No restrictions on number radiotherapy fractions, or location/number of lesions

Disqualifiers

Step 1- Exclusion Criteria

Prior lung cancer-directed radiotherapy

Recent (< 12 mo) or planned lung surgery (which would confound pre- and post-RT lung function measures)

Patients with metal implants or metal stents in the thoracic region

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Arm 1- SOC Radiation PlanActive comparator 1 intervention
Group B: Arm 2- INSPIRE Radiation PlanExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Measurement of Post-Radiation retention of ventilation at 12 months through imaging.

The central objective of this trial is to determine if dose-sparing of airways and connected high-functioning sub-lobar lung volumes leads to superior preservation of post-RT ventilation compared to that achieved through SOC RT

Time frame
12 months

Secondary outcomes

1

Number of patients with Grade 2 or higher toxicities defined by Common Terminology Criteria for Adverse Events (CTCAE) v5

Local-regional control, radiographically-assessed change in radiation pneumonitis/lung fibrosis, Grade ≥ 2 toxicity per CTCAE definition.

Time frame
12 months

Other outcomes

Sponsors and contacts

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