early stage non-small cell lung cancer with interstitial lung disease
Conditions
Interventions
ILD-GAP = 2:SBRT vs SBRT and nintedanib
ILD-GAP 3-5:SBRT vs SBRT and nintedanib
ILD-GAP=6:SBRT vs SBRT and nintedanib
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Each subject must meet all the following criteria to be included in this study: 1. Sign the written informed consent; 2. Age 18 to 85 years; ECOG PS 0 to 1; Estimated survival time >= 6 months; 3. Stage T1-2N0M0 non-small cell lung cancer diagnosed clinically or pathologically (IASLC staging 8th edition); 4. In line with the "Rare Disease Diagnosis and Treatment Guidelines 2019" issued by the National Health and Family Planning Commission, the main diagnostic conditions for idiopathic pulmonary fibrosis: A. Except for interstitial lung diseases caused by other known causes, such as occupational exposure, indoor and outdoor environmental exposure , Connective tissue disease and drug-induced lung damage, etc.; B. In patients who did not undergo surgical lung biopsy, HRCT showed the UIP type of ordinary interstitial pneumonia (UIP); UIP judgment criteria on HRCT: (1) Typical UIP type (all 4 characteristics): The lesions are mainly located under the pleura and the base of the lung; abnormal grid-like shadow and honeycomb changes, with or without tractive bronchiectasis, are all types that are not in line with UIP (see whether Comply with UIP type); (2) Possible UIP type (all 3 features): the lesions are mainly located under the pleura and abnormal grid-like shadows at the base of the lung; there is no one that does not meet the UIP type (see the UIP type column); (3) Does not meet the UIP type (any one of the 7 characteristics): the lesions are mainly distributed in the upper and middle lung lesions mainly along the bronchial vascular bundles, extensive ground glass-like shadows (the range exceeds the grid-like shadows), and a large number of micro-nodules ( Bilateral, upper lungs are mainly distributed), scattered cystic lesions (multiple, bilateral, away from the honeycomb lung area), diffuse mosaic sign/gas trapping (bilateral, three or multiple lobes involved), bronchopulmonary segment/ Lobe consolidation 5. Disease classification standards (based on clinical lung function classification) Severe: TLC (total lung volume) or DLco (diffusion function) <= 39%; or unable to complete lung function test; Moderate: 40% <= TLC (total lung capacity) or DLco (diffusion function) <= 59%; Mild: 60% <= TLC (total lung capacity) or DLco (diffusion function) <= 79%; Normal: 80% <= TLC (total lung capacity) or DLco (diffusion function). 6. The subject has not received any treatment for NSCLC; The subjects voluntarily joined the study, signed an informed consent form, had good compliance and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria should be excluded from this study: 1. Combined with tuberculosis, fungus, pulmonary infection, etc. and other primary lung diseases; 2. Patients with severe complications of other diseases such as cardiovascular, urinary, digestive, hematopoietic, endocrine and metabolic systems, liver and kidney insufficiency, and mental illness; 3. Pregnant or lactating women patients; 4. Those who do not follow the doctor's advice, cannot judge the curative effect, or the clinical data is incomplete and affect the judgment of curative effect 5. Those who have poor compliance or judged by the doctor to be unable to cooperate; 6. Those who have participated in other clinical trials for three months; 7. Other situations that the researcher believes that the subject is not suitable for participation; Patients who refused to sign the informed consent form after a targeted explanation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival;Objective response rate;Disease control rate;Adverse Event; | — |
Countries
China
Contacts
Public ContactXiao-Shuai Yuan
Shanghai Pulmonary Hospital
Outcome results
None listed