Assessment of precision irradiation in early non-small cell lung cancer and interstitial lung disease (ASPIRE-ILD): study protocol for a phase II trial.
Adolescent
Adult
Aged
Aged, 80 and over
Carcinoma, Non-Small-Cell Lung
/ pathology
Female
Humans
Lung Diseases, Interstitial
/ pathology
Lung Neoplasms
/ pathology
Male
Middle Aged
Neoplasm Staging
Prospective Studies
Radiosurgery
/ adverse effects
Radiotherapy Dosage
Tomography, X-Ray Computed
/ methods
Treatment Outcome
Young Adult
Cancer
Interstitial lung disease
Lung
Stereotactic radiotherapy
Survival
Toxicity
Journal
BMC cancer
ISSN: 1471-2407
Titre abrégé: BMC Cancer
Pays: England
ID NLM: 100967800
Informations de publication
Date de publication:
11 Dec 2019
11 Dec 2019
Historique:
received:
12
07
2019
accepted:
21
11
2019
entrez:
13
12
2019
pubmed:
13
12
2019
medline:
30
5
2020
Statut:
epublish
Résumé
Stereotactic ablative radiotherapy (SABR) has become an established treatment option for medically-inoperable early-stage (Stage I-IIA) non-small cell lung cancer (ES-NSCLC). SABR is able to obtain high rates of local control with low rates of symptomatic toxicity in this patient population. However, in a subset of patients with fibrotic interstitial lung disease (ILD), elevated rates of SABR-related toxicity and mortality have been described. The Assessment of Precision Irradiation in Early Non-Small Cell Lung Cancer and Interstitial Lung Disease (ASPIRE-ILD) study will conduct a thorough prospective evaluation of the clinical outcomes, toxicity, changes in diagnostic test parameters and patient-related outcomes following SABR for ES-NSCLC for patients with fibrotic ILD. ASPIRE-ILD is a single-arm Phase II prospective study. The accrual target is 39 adult patients with T1-2N0M0 non-small cell lung cancer with co-existing ILD who are not candidates for surgical excision. Pathological confirmation of diagnosis is strongly recommended but not strictly required. Enrolled patients will be stratified by ILD-related mortality risk. The starting SABR dose will be 50 Gy in 5 fractions every other day (biologically effective dose: 100 Gy ASPIRE-ILD will be the first prospective study specifically designed to comprehensively evaluate the effectiveness and safety of SABR for ES-NSCLC in patients with co-existing ILD. Clinicaltrials.gov identifier: NCT03485378. Date of registration: April 2, 2018.
Sections du résumé
BACKGROUND
BACKGROUND
Stereotactic ablative radiotherapy (SABR) has become an established treatment option for medically-inoperable early-stage (Stage I-IIA) non-small cell lung cancer (ES-NSCLC). SABR is able to obtain high rates of local control with low rates of symptomatic toxicity in this patient population. However, in a subset of patients with fibrotic interstitial lung disease (ILD), elevated rates of SABR-related toxicity and mortality have been described. The Assessment of Precision Irradiation in Early Non-Small Cell Lung Cancer and Interstitial Lung Disease (ASPIRE-ILD) study will conduct a thorough prospective evaluation of the clinical outcomes, toxicity, changes in diagnostic test parameters and patient-related outcomes following SABR for ES-NSCLC for patients with fibrotic ILD.
METHODS
METHODS
ASPIRE-ILD is a single-arm Phase II prospective study. The accrual target is 39 adult patients with T1-2N0M0 non-small cell lung cancer with co-existing ILD who are not candidates for surgical excision. Pathological confirmation of diagnosis is strongly recommended but not strictly required. Enrolled patients will be stratified by ILD-related mortality risk. The starting SABR dose will be 50 Gy in 5 fractions every other day (biologically effective dose: 100 Gy
DISCUSSION
CONCLUSIONS
ASPIRE-ILD will be the first prospective study specifically designed to comprehensively evaluate the effectiveness and safety of SABR for ES-NSCLC in patients with co-existing ILD.
TRIAL REGISTRATION
BACKGROUND
Clinicaltrials.gov identifier: NCT03485378. Date of registration: April 2, 2018.
Identifiants
pubmed: 31829203
doi: 10.1186/s12885-019-6392-8
pii: 10.1186/s12885-019-6392-8
pmc: PMC6905060
doi:
Banques de données
ClinicalTrials.gov
['NCT03485378']
Types de publication
Clinical Trial Protocol
Clinical Trial, Phase II
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
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