Radiation-induced lung injury
Conditions
Interventions
trial group:Pirfenidone
control group:placebo
Sponsors
Fujian Medical University Union Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged from 18 to 75, regardless of gender; 2. Subjects with ECoG score of 0-1; 3. Patients with pathological diagnosis of esophageal squamous cell carcinoma; 4. Patients with upper and middle thoracic esophageal cancer (the primary focus is mainly in the chest); 5. Patients with ct3-4n + M0 thoracic esophageal carcinoma (AJCC stage, 8th Edition); 6. Patients have no indications for initial surgery due to physical reasons or locally advanced tumors; 7. Patients with esophageal cancer without perforation or deep niche; 8. Subjects who can eat liquid food; 9. Subjects who had not received anti-tumor drugs (chemotherapy, immunity, etc.) or surgery before radiotherapy; 10. Subjects whose bone marrow, liver, kidney and lung functions are acceptable by laboratory examination; 11. Patients whose expected survival period is more than 6 months; 12. The subjects who voluntarily participate in this study have good compliance and can complete the observation and follow-up according to the requirements of the experiment.
Exclusion criteria
Exclusion criteria: 1. Patients who have received chest radiotherapy in the past; 2. Patients with other malignant tumors (except for non melanin skin cancer, cervical cancer in situ or cured early prostate cancer); 3. Patients with abnormal coagulation function, bleeding tendency (such as active peptic ulcer) or receiving thrombolytic or anticoagulant therapy; 4. Patients with history of interstitial lung disease and non infectious pneumonia; 5. Patients with active connective tissue disease, especially scleroderma, systemic lupus erythematosus or collagen vascular disease; 6. Patients with severe cardiopulmonary diseases (congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina pectoris, myocardial infarction within half a year, severe heart valve disease and intractable hypertension, etc.), uncontrolled infectious diseases and other non tumor related diseases make the patients unable to tolerate comprehensive treatment such as radiotherapy and chemotherapy; 7. The subjects with mental illness or other reasons can not sign the informed consent; 8. For the subjects with poor medical compliance, the study group thought that the patients could not complete the trial treatment process and follow-up according to the standard.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of level 2 and above radiation-induced lung injury; | — |
Countries
China
Contacts
Public ContactBenhua Xu
Union Hospital Affiliated to Fujian Medical University
Outcome results
None listed