DRUG
Concurrent chemotherapy
Concurrent chemotherapy consists of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1 day's duration.
Status
Completed
Phase
Phase 2
Enrollment
69
Locations
1
Results
Not posted
Publications
12
Study summary
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.
Interventions
DRUG
Concurrent chemotherapy consists of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1 day's duration.
RADIATION
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
DRUG
subcutaneous injections of thymosin once a week,1.6mg each time from the start of radiation to 2 months after the end of radiation.
Timeline
First posted
Sep 6, 2018
Study start
Aug 9, 2018
Primary completion
Sep 30, 2021
Study completion
Sep 30, 2021
Results posted
Not reported
Registry updated
Jan 3, 2022
Outcomes
Incidence of ≥grade 2 radiation pneumonitis (CTCAE 5.0 version)
Time frame · 1-year
Radiation-induced pneumonitis except other reasons induced pneumonia
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
Eligibility
Inclusion Criteria: * Pathologic confirmation of NSCLC. * Patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. * Unresectable phase IIIA-IIIC lung cancer confirmed by PET/CT, CT or MRI. * Whole lung V20\>=35% when giving 60Gy which is the minimum dose of radical irradiation. * Eastern Cooperative Oncology Group (ECOG) performance status 0-1. * Previously treated with chemotherapy or treatment-naive * No previous chest radiotherapy, immunotherapy or biotherapy * Hemoglobin≥10 mg/dL, platelet≥100000/μL,absolute neutrophil count ≥1500/μL * Serum creatinine ≤1.25 times the upper normal limit(UNL), or creatinine clearance≥60 ml/min * Bilirubin ≤1.5 times UNL, AST(SGOT)≤2.5 times UNL ,ALT(SGPT)≤2.5 times UNL,alkaline phosphatase ≤5 times UNL * FEV1 \>0.8 L * CB6 within normal limits * patients and their family signed the informed consents Exclusion Criteria: * Previous or recent another malignancy, except nonmelanoma skin cancer or cervical cancer in situ * Contraindication for chemotherapy * Malignant pleural or pericardial effusion. * Women in pregnancy, lactation period, or no pregnancy test 14 days before the first dose * Women who has the probability of pregnancy without contraception * Tendency of hemorrhage * In other clinical trials within 30 days * Addicted in drugs or alcohol, AIDS patients * Uncontrollable seizure or psychotic patients without self-control ability * Severe allergy or idiosyncrasy * Not suitable for this study judged by researchers
Study locations
China. Showing up to 24 locations stored in the fast local snapshot.
Sun yat-sen University Cancer Center
Guangzhou, Guangdong, China
Publications
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