Prevention of Locally Advanced NSCLC Radiotherapy Pneumonia by Inhaling Beclomethasone Propionate

Locally Advanced Non Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03886441
• Other study ID #: fk1416
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 1, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: March 2019
• Source: Tongji University
• Contact: caicun zhou, phD MD
• Phone: 8621-65115006-3050
• Email: caicunzhoudr[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 194
• Est. completion date: December 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Locally Advanced Non Small Cell Lung Cancer
• Pneumonia

Intervention

Drug:
• Beclomethasone propionate
Beclomethasone propionate inhaled twice daily during radiotherapy

Locations

Country	Name	City	State
China	Medical Department, Shanghai Pulmonary Hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Tongji University	Shanghai Pulmonary Hospital, Shanghai, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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.
Secondary	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.
Secondary	Side effects between two groups of patients	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 .