GCC 2545- Improving Post-Radiotherapy Respiratory Function Through Sparing Serial and Parallel Components in the Lung (INSPIRE)
29 juni 2026 uppdaterad av: Amit Sawant, University of Maryland, Baltimore
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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
70
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Amit Sawant, PhD
- Telefonnummer: 410-328-6080
- E-post: asawant@som.umaryland.edu
Studera Kontakt Backup
- Namn: Caitlin Eggleston, MPH
- Telefonnummer: 410-369-5351
- E-post: caitlineggleston@umm.edu
Studieorter
-
-
Maryland
-
Baltimore, Maryland, Förenta staterna, 21201
- University of Maryland Greenebaum Cancer Center
-
Kontakt:
- Caitlin Eggleston, MPH
- Telefonnummer: 410-369-5351
- E-post: caitlineggleston@umm.edu
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inclusion Criteria:
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
- ECOG performance status ≤ 3
- Ability to hold breath for ≥ 15 seconds
- Patient has signed informed consent document and agreed to study procedures
Step 2- Inclusion Criteria 1. Patient has completed 4DCT and BHCT with subsequent plans created and Radiation Oncologist has determined that patient would benefit from INSPIRE RT.
Exclusion Criteria:
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
- Known severe chronic obstructive pulmonary disease or interstitial lung disease
- Women who are pregnant or trying to get pregnant
Step 2- Exclusion Criteria
1. Patient found to not benefit from INSPIRE RT after comparison of treatment plans.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Arm 1- SOC Radiation Plan
Standard RT Plan Creation
|
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
|
|
Experimentell: 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.
|
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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Measurement of Post-Radiation retention of ventilation at 12 months through imaging.
Tidsram: 12 months
|
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
|
12 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Number of patients with Grade 2 or higher toxicities defined by Common Terminology Criteria for Adverse Events (CTCAE) v5
Tidsram: 12 months
|
Local-regional control, radiographically-assessed change in radiation pneumonitis/lung fibrosis, Grade ≥ 2 toxicity per CTCAE definition.
|
12 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Amit Sawant, PhD, University of Maryland, Baltimore
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 augusti 2026
Primärt slutförande (Beräknad)
1 augusti 2028
Avslutad studie (Beräknad)
1 augusti 2030
Studieregistreringsdatum
Först inskickad
23 juni 2026
Först inskickad som uppfyllde QC-kriterierna
29 juni 2026
Första postat (Faktisk)
1 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
1 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
29 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- HP-00114566
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .