DIILD
Conditions
Interventions
None listed
Sponsors
European Organisation for Research in Treatment of Cancer (EORTC)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Age * 18 years * WHO performance status 0-2 * Life expectancy > 6 months * Proven cancer diagnosis in a patient actively undergoing systemic anticancer therapy * New onset symptoms (e.g. cough, fever, dyspnoea, and hypoxia) at any time during or within 4 weeks of the last dose of anti-cancer treatment * New onset radiological (CXR or CT) abnormalities within the lungs at any time during or within 4 weeks of the last dose of anti-cancer treatment (e.g. diffuse lung changes, infiltrative opacification in the periphery of the lung or ground glass changes) with a locally reviewed diagnosis of DIILD as the most likely explanation for the radiological abnormalities. * Treatment for DIILD planned (e.g. drug withdrawal, interruption +/- supportive therapy including corticosteroids, oxygen, bronchodilators etc.). Treatment with antibiotics, anticoagulants etc. is permitted pending results of investigations for differential diagnoses. * Able to undergo pulmonary function tests (at a minimum spirometry and gas transfer (DLCO)) * Patients enrolled on other anti-cancer investigational trials are permitted at investigator discretion * Informed written consent obtained according to ICH/GCP, and national/local regulations * Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test within 14 days before study registration
Exclusion criteria
Exclusion criteria: * Primary lung tumor greater than 3cm * Lung metastatic lesion > 2cm or greater than 5 metastases * Claustrophobia, or inability to undergo non-contrast CT examination * Known or suspected non-drug related ILD (e.g. lung abnormalities due to other causes such as occupational exposure) * Previous thoracic lobectomy * Clinical, radiological or microbiological evidence of active lower respiratory tract infection * Currently active, clinically significant heart disease, such as uncontrolled class 3 or 4 congestive heart failure defined by the New York Heart Association Functional Classification * Any medical, psychological, sociological or geographical condition that could affect participation in the study and compliance with the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Relative change of FVC between study entry (DIILD diagnosis) and 6 weeks after diagnosis (treatment adaptation) - Relative change in the semi-quantitative radiology scores between study entry (DIILD diagnosis) and 6 weeks after diagnosed DIILD (treatment adaptation) | — |
Secondary
| Measure | Time frame |
|---|---|
| To be evaluated at study entry, at 6 weeks and 6 months: * FVC * Other pulmonary physiology results (e.g. DLCO and 6MWT) * Respiratory patient report outcome * Quality of life To be evaluated at study entry and at 6 weeks: * Radiology qualitative analysis (3 grading) * Quantitative volumetric inspiratory CT measurements | — |
Countries
Netherlands
Outcome results
None listed