Journal Article

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

Chen, Hanbo, Gaede, Stewart, Dhaliwal, Inderdeep, Yu, Edward, Palma, David A., Rodrigues, George B., Laba, Joanna M., Ryerson, Christopher J., Qu, X. Melody, Harrow, Stephen, Yaremko, Brian P., Bahig, Houda, Louie, Alexander V.

2019

Overview

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 Gy 10 or 217 Gy 3 ), but the radiation dose can be de-escalated up to two times to 50 Gy in 10 fractions daily (75 Gy 10 or 133 Gy 3 ) and 45 Gy in 15 fractions daily (58 Gy 10 or 90 Gy 3 ). 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.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Adolescent / Adult / Aged / Aged, 80 and over / Analysis / Biomedical and Life Sciences / Biomedicine / Cancer / Cancer Research / Cancer therapies / Carcinoma, Non-Small-Cell Lung - pathology / Carcinoma, Non-Small-Cell Lung - radiotherapy / Care and treatment / CAT scans / Clinical trials / Clinical Trials, Phase II as Topic / Computed tomography / Cough / Female / Fractions / Health aspects / Health Promotion and Disease Prevention / Humans / Interstitial lung disease / Lung / Lung cancer / Lung diseases / Lung Diseases, Interstitial - pathology / Lung Diseases, Interstitial - radiotherapy / Lung Neoplasms - pathology / Lung Neoplasms - radiotherapy / Male / Medical and radiation oncology / Medical prognosis / Medical research / Medicine/Public Health / Meta-analysis / Middle Aged / Mortality / Neoplasm Staging / Non-small cell lung cancer / Non-small cell lung carcinoma / Oncology / Patients / Prospective Studies / Quality of life / Radiation (Physics) / Radiation therapy / Radiosurgery - adverse effects / Radiosurgery - methods / Radiotherapy / Radiotherapy Dosage / Respiratory function / Small cell lung cancer / Small cell lung carcinoma / Stereotactic radiotherapy / Study Protocol / Surgery / Surgical Oncology / Survival / Tomography / Tomography, X-Ray Computed - methods / Toxicity / Treatment Outcome / Young Adult