Status:
UNKNOWN
The Efficacy of Babaodan Capsules in Preventing Radiation Pneumonia
Lead Sponsor:
Fifth Affiliated Hospital, Sun Yat-Sen University
Conditions:
Radiation Pneumonitis
Eligibility:
All Genders
17-70 years
Phase:
PHASE2
Brief Summary
Radiation pneumonitis (RP) is a common complication of radiotherapy for thoracic tumors, and the incidence rate of grade 2 or above RP is 20% -40%; The use of antibiotics after secondary bacterial inf...
Detailed Description
Radiation induced lung injury (RILI) is a common complication of chest radiation therapy, which can be divided into two stages, including radiation pneumonia (RP) and pulmonary fibrosis (RPF), with di...
Eligibility Criteria
Inclusion
- （1）18 to 70 years；（2）Histologically/cytologically confirmed NSCLC；（3）ECOG ≤2；（4）Weight loss ≤10%；（5） Inoperable AJCC stage IIIA, or IIIB disease；（6）Neutrophils ≥1.5×10\^9/L and platelets ≥100×10\^9/L；（7）Adequate liver and renal function.
Exclusion
- （1）Malignant pleural effusion；（2）Active uncontrolled infection；（3）Significant cardiovascular disease；（4）History of other malignancies；（5）Forced expiratory volume in 1 second \<40% of normal；（6）Previous history of cervical and chest radiation therapy.
Key Trial Info
Start Date :
December 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06079931
Start Date
December 5 2024
End Date
December 1 2025
Last Update
March 20 2024
Active Locations (1)
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1
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, China, 519000