radiation pneumonitis
Conditions
Interventions
Control group.:Conventional thoracic radiotherapy.
Nintedanib group.:Radiotherapy combined with nintedanib
Sponsors
HenanCancerHospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Histologically or cytologically confirmed, unresectable non-small cell lung cancer (squamous cell carcinoma, adenocarcinoma, large-cell carcinoma, or other unspecified NSCLC) requiring definitive concurrent or sequential chemoradiotherapy; 2.Consolidation immunotherapy after definitive radiotherapy is unrestricted, provided that critical organ function is preserved. 3.Age >=18 years; 4.Performance status: Karnofsky Performance Status (KPS) >= 70; Eastern Cooperative Oncology Group (ECOG) PS 0–2. 5.Routine laboratory tests show no significant abnormalities (hematology, liver/kidney function, coagulation, etc.). 6.No hypoxemia or hypercapnia at rest; no pulmonary hypertension; no severe cardiac, cerebrovascular, or peripheral vascular disease; 7.Male and female patients of childbearing potential must use effective contraception throughout the entire course of the study. 8.Male and female patients of childbearing potential must use effective contraception throughout their participation in this study; 9.Estimated life expectancy >= 6 months. 10.Voluntarily agrees to participate and signs a written informed consent form, and is willing to comply with and complete full follow-up.
Exclusion criteria
Exclusion criteria: 1.History of another malignancy within the past 5 years, except for adequately controlled basal cell carcinoma of the skin, cervical carcinoma in situ, or ductal carcinoma in situ of the breast. 2.Patients who have previously received lung (thoracic) radiotherapy; those who received induction immunotherapy prior to definitive chemoradiotherapy. 3.Non-infectious pneumonitis or concomitant severe respiratory diseases (e.g., chronic obstructive pulmonary disease [COPD], active tuberculosis). 4.Presence of severe gastrointestinal diseases that affect medication administration or absorption, including but not limited to peptic ulcer disease and inflammatory bowel disease. 5.Subjects with hypersensitivity to nintedanib or similar tyrosine kinase inhibitors; active liver disease (e.g., Child–Pugh class B/C cirrhosis) or ALT/AST > 3× the upper limit of normal (ULN); severe renal impairment (eGFR < 30 mL/min/1.73 m²). 6.Patients with severe cardiopulmonary disease, other significant comorbidities, or infections that render them unable to tolerate treatment. 7.Pregnant or breastfeeding women, given the potential for unforeseeable risks to the embryo or fetus; 8.History of severe neurological or psychiatric disorders, including dementia; 9.Patients who are unable to complete radiotherapy. 10.Refusal or inability to provide written informed consent; refusal to comply with follow-up;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of grade =2 radiation pneumonitis.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS).;Severity of radiation pneumonitis.;Overall survival (OS).; | — |
Countries
China
Contacts
Public ContactXiaoli Zheng
Henan Provincial Cancer Hospital
Outcome results
None listed