Clinical trial NCT03886441: Prevention of Locally Advanced NSCLC Radiotherapy Pneumonia by Inhaling Beclomethasone Propionate
Official title: A Randomized, Open Phase II Study of the Incidence and Safety of Radiation Pneumonia in Patients With Locally Advanced NSCLC Treated With Beclomethasone Propionate Inhaled During Radical Radiotherapy Compared With Conventional Radiotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Locally Advanced Non Small Cell Lung Cancer
Keywords: beclomethasone propionate
radiation pneumonitis
NSCLC
radical radiotherapy
Preventive effect
Lead sponsor: Tongji University
Sponsor class: OTHER
Collaborators: name: Shanghai Pulmonary Hospital, Shanghai, China
First posted: 2019-03-22
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. The subjects understood the requirements and risks of the study fully and signed the informed consent form.
2. Aged between 18 and 70 years;
3. Histologically or cytologically confirmed diagnosis of locally advanced non-small cell lung cancer.
4. All of these patients have pointers to radical radiation and can't be treated surgically.
5. ECOG PS of 0-2;
6. 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.
7. Adequate hematologic function:

   Peripheral blood neutrophil count \> 2000 cells / uL, Platelet count \> 100\*109 / L; Hemoglobin \>9.0g/dL;
8. Blood total bilirubin \< 2 times normal upper limit, blood AST and ALT ≤ 2. 5 times normal upper line;
9. Inosine clearance ≥ 60ml / min;
10. Life expectancy of at least 12weeks.

Exclusion Criteria:

1. With severe or uncontrolled systemic diseases;
2. With a history of asthma, systemic immune diseases, such as the need for long-term hormone treatment in patients;
3. The lung function decreased obviously;
4. Those receiving targeted therapy or biological therapy at the same time;
5. Allergic to beclomethasone propionate;
6. Pregnant or lactating women;
7. Accompanied by uncontrolled diabetes, need to take oral hormone treatment of sarcoidosis and vasculitis, lupus erythematosus and other immune diseases;
8. In recent 5 years has suffered from other tumors: cervical cancer, basal cell carcinoma of the skin, and so on;
9. The estimated survival time was less than 3 months.

Primary outcomes:
measure: Incidence of radiation pneumonia between two groups of patients
timeFrame: Chest CT assessment every 6 weeks since thoracic irradiation, up to 36 weeks.
Secondary outcomes:
measure: Objective Response Rate between two groups of patients
timeFrame: tumor assessment every 6 weeks since thoracic irradiation , up to 36 weeks.
measure: Side effects between two groups of patients
timeFrame: 36 weeks .
Other outcomes:
measure: Quality of life between two groups of patients
timeFrame: 36 weeks
Locations:
city: Shanghai
country: China
facility: Medical Department, Shanghai Pulmonary Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Pulmonary Hospital, Tongji University
name: caicun zhou, phD MD
role: PRINCIPAL_INVESTIGATOR
References: