Study of Thymosin α1 to Reduce Acute Pneumonia For Bulky None-small Cell Lung Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II Study of Thymopeptide a1 During Split-course Chemoradiotherapy to Reduce Acute Pneumonia For Bulky None-small Cell Lung Cancer

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Concurrent chemotherapy
* Radiation: split-course radiotherapy
* Drug: thymosin alpha 1


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thymosin α1<br>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. | Drug: Concurrent chemotherapy<br>* Concurrent chemotherapy consists of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1 day's duration.<br>Radiation: split-course radiotherapy<br>* 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<br>Drug: thymosin alpha 1<br>* subcutaneous injections of thymosin once a week,1.6mg each time from the start of radiation to 2 months after the end of radiation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of ≥grade 2 radiation pneumonitis (CTCAE 5.0 version) | Radiation-induced pneumonitis except other reasons induced pneumonia | 1-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-small Cell Lung Cancer, Split-course Chemoradiotherapy, Thymosin a1