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| Name | Class |
|---|---|
| Shanghai Pulmonary Hospital, Shanghai, China | OTHER |
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Radical radiotherapy is the main treatment of locally advanced lung cancer, and radiation pneumonia is the main toxic effects of radiotherapy. Among them, the fatality rate of severe radiation pneumonia can reach 50%, which is very harmful to tumor patients. At present, the treatment mode of radiation pneumonia is very few, and the therapeutic effect is poor. The prevention of radiation pneumonitis may be the best way to reduce the number of patients with Post-radiotherapy pneumonia. Previous small clinical studies have shown that the incidence of radiation pneumonia in inhaled beclomethasone group (2 /28) was significantly lower than that in oral prednisone group (8 /29) during radiotherapy. The purpose of this study was to compare the efficacy and safety of radiotherapy between the therapeutic group (inhaled beclomethasone during radiotherapy) and the control radiotherapy group (patients received radiotherapy only), especially the incidence of radiation-induced pneumonia within half a year.
To compare the incidence of radiation pneumonia, effect and side effects of radiotherapy in lung between beclomethasone inhalation therapeutic group and control radiotherapy group in patients with locally advanced non-small cell lung cancer (NSCLC) during radiotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prevention group | Experimental | Participants inhaled beclomethasone propionate aerosol daily during chest radical radiotherapy (total dose 60GY). |
|
| Traditional therapy group | No Intervention | Participants were not given daily inhalation of beclomethasone propionate when undergoing radical chest radiotherapy (total dose 60GY). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beclomethasone propionate | Drug | Beclomethasone propionate inhaled twice daily during radiotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of radiation pneumonia between two groups of patients | To evaluate the incidence of radiation pneumonia in 36weeks since thoracic irradiation between two groups of patients | Chest CT assessment every 6 weeks since thoracic irradiation, up to 36 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate between two groups of patients | To evaluate Objective response rate every 6weeks since thoracic irradiation. | tumor assessment every 6 weeks since thoracic irradiation , up to 36 weeks. |
| Side effects between two groups of patients |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life between two groups of patients | evaluated every 6 weeks since the thoracic irradiation began according to the EORTC Quality-of-Life Questionnarire-Lung Cancer 13 Module(EORTC OLO-LC13) | 36 weeks |
Inclusion Criteria:
The subjects understood the requirements and risks of the study fully and signed the informed consent form.
Aged between 18 and 70 years;
Histologically or cytologically confirmed diagnosis of locally advanced non-small cell lung cancer.
All of these patients have pointers to radical radiation and can't be treated surgically.
ECOG PS of 0-2;
Women of childbearing age had negative pregnancy tests and were willing to accept drugs or intrauterine contraception, while men of childbearing age were willing to accept contraception voluntarily.
Adequate hematologic function:
Peripheral blood neutrophil count > 2000 cells / uL, Platelet count > 100*109 / L; Hemoglobin >9.0g/dL;
Blood total bilirubin < 2 times normal upper limit, blood AST and ALT ≤ 2. 5 times normal upper line;
Inosine clearance ≥ 60ml / min;
Life expectancy of at least 12weeks.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| caicun zhou, phD MD | Contact | 8621-65115006-3050 | caicunzhoudr@126.com | |
| jie zhang, MD | Contact | 13501878890 | zhangjie2172@163.com |
| Name | Affiliation | Role |
|---|---|---|
| caicun zhou, phD MD | Shanghai Pulmonary Hospital, Tongji University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Department, Shanghai Pulmonary Hospital | Shanghai | Shanghai Municipality | 200433 | China |
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| ID | Term |
|---|---|
| D017564 | Radiation Pneumonitis |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D055370 | Lung Injury |
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| ID | Term |
|---|---|
| C065857 | beclomethasone 17-monopropionate |
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To evaluated in the 36 weeks since the thoracic irradiation began according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 |
| 36 weeks . |
| D011832 |
| Radiation Injuries |
| D014947 | Wounds and Injuries |