Assessment of precision irradiation in early non-small cell lung cancer and interstitial lung disease (ASPIRE-ILD): study protocol for a phase II trial

Autor: Houda Bahig, David A. Palma, Stephen Harrow, Stewart Gaede, Hanbo Chen, Edward Yu, Joanna Laba, George Rodrigues, Alexander V. Louie, X. Melody Qu, Christopher J. Ryerson, Inderdeep Dhaliwal, Brian Yaremko
Jazyk: angličtina
Rok vydání: 2019
Předmět:
0301 basic medicine
Oncology
Male
Cancer Research
Lung Neoplasms
Exacerbation
Survival
medicine.medical_treatment
SABR volatility model
Pulmonary function testing
Study Protocol
0302 clinical medicine
Carcinoma
Non-Small-Cell Lung
Clinical endpoint
Stereotactic radiotherapy
Prospective Studies
Prospective cohort study
Lung
Cancer
Aged
80 and over
Interstitial lung disease
Radiotherapy Dosage
respiratory system
Middle Aged
lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens
Treatment Outcome
030220 oncology & carcinogenesis
Female
Adult
medicine.medical_specialty
Adolescent
Radiosurgery
lcsh:RC254-282
03 medical and health sciences
Young Adult
Internal medicine
Genetics
medicine
Humans
Lung cancer
Aged
Neoplasm Staging
Toxicity
business.industry
medicine.disease
respiratory tract diseases
Radiation therapy
030104 developmental biology
business
Lung Diseases
Interstitial
Tomography
X-Ray Computed
Zdroj: BMC Cancer
BMC Cancer, Vol 19, Iss 1, Pp 1-17 (2019)
ISSN: 1471-2407
Popis: 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 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 Gy10 or 217 Gy3), but the radiation dose can be de-escalated up to two times to 50 Gy in 10 fractions daily (75 Gy10 or 133 Gy3) and 45 Gy in 15 fractions daily (58 Gy10 or 90 Gy3). Dose de-escalation will occur if 2 or more of the first 7 patients in a cohort experiences grade 5 toxicity within 6 months of treatment. Similarly, dose de-escalation can also occur if 2 or more of the first 7 patients with a specific subtype of ILD experiences grade 5 toxicity within 6 months of treatment. The primary endpoint is overall survival. Secondary endpoints include toxicity (CTC-AE 4.0), progression-free survival, local control, patient-reported outcomes (cough severity and quality of life), rates of ILD exacerbation and changes in pulmonary function tests/high-resolution computed tomography findings post-SABR. Discussion 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 Clinicaltrials.gov identifier: NCT03485378. Date of registration: April 2, 2018.
Databáze: OpenAIRE
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