Non-small Cell Lung Cancer
Conditions
Keywords
Non-small Cell Lung Cancer, Split-course Chemoradiotherapy, Thymosin a1
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.
Interventions
DRUGConcurrent chemotherapy
Concurrent chemotherapy consists of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1 day's duration.
RADIATIONsplit-course radiotherapy
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
DRUGthymosin alpha 1
subcutaneous injections of thymosin once a week,1.6mg each time from the start of radiation to 2 months after the end of radiation.
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of ≥grade 2 radiation pneumonitis (CTCAE 5.0 version) | 1-year | Radiation-induced pneumonitis except other reasons induced pneumonia |
Secondary
| Measure | 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 |
Other
| Measure | Time frame |
|---|---|
| Alpha diversity of gut microbiota as the exploratory outcome | From baseline to the end of CCRT, an average of 2 months |
Countries
China
Outcome results
None listed