This Phase II study is to determine the efficacy of Thymosin α1 on the frequency of acute pneumonia in non-small cell lung cancer with bulky tumor.
This Phase II study is to determine the efficacy of Thymosin α1 on the frequency of radiation pneumonitis in non-small cell lung cancer with bulky tumor. All patients received four cycles of weekly docetaxel (25mg/㎡) and nedaplatin (25mg/㎡)(DP), each of 1 day's duration, combined with split-course thoracic radiotherapy of 51 Gy in 17 fractions or 40 Gy in 10 fractions as the first course followed by a break of four weeks. Patients without disease progression had a dose of 15 Gy in 5 fractions or 24 Gy in 6 fractions as a boost. Patients were further treated with subcutaneous injections of thymosin once a week,1.6mg each time from the start of radiation to 2 months after the end of radiation. Toxicities will be graded according to CTCAE v. 4.0.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
69
Concurrent chemotherapy consists of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1 day's duration.
Patient was administered with 51 Gy in 17 fractions or 40 Gy in 10 fractions as the first course followed by a break of four weeks. Patients without disease progression had a dose of 15 Gy in 5 fractions or 24 Gy in 6 fractions as a boost
subcutaneous injections of thymosin once a week,1.6mg each time from the start of radiation to 2 months after the end of radiation.
Sun yat-sen University Cancer Center
Guangzhou, Guangdong, China
Incidence of ≥grade 2 radiation pneumonitis (CTCAE 5.0 version)
Radiation-induced pneumonitis except other reasons induced pneumonia
Time frame: 1-year
Total lymphocyte count
Time frame: From the beginning of CCRT until 6 months after the completion of CCRT.
C-reaction protein
Time frame: From the beginning of CCRT until 6 months after the completion of CCRT.
grade of pulmonary fibrosis (CTCAE 5.0 version)
Time frame: 1-year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.