Study of Thymosin α1 to Reduce Acute Pneumonia For Bulky None-small Cell Lung Cancer
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Registration Number
- NCT03659578
- Lead Sponsor
- Sun Yat-sen University
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 69
-
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.
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Previously treated with chemotherapy or treatment-naive
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No previous chest radiotherapy, immunotherapy or biotherapy
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Hemoglobin≥10 mg/dL, platelet≥100000/μL,absolute neutrophil count ≥1500/μL
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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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Thymosin α1 thymosin alpha 1 Patients are 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. Thymosin α1 Concurrent chemotherapy Patients are 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. Thymosin α1 split-course radiotherapy Patients are 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.
- Primary Outcome Measures
Name Time Method Incidence of ≥grade 2 radiation pneumonitis (CTCAE 5.0 version) 1-year Radiation-induced pneumonitis except other reasons induced pneumonia
- Secondary Outcome Measures
Name Time Method Total lymphocyte count From the beginning of CCRT until 6 months after the completion of CCRT. C-reaction protein From the beginning of CCRT until 6 months after the completion of CCRT. grade of pulmonary fibrosis (CTCAE 5.0 version) 1-year
Trial Locations
- Locations (1)
Sun yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China