Prevention of Locally Advanced NSCLC Radiotherapy Pneumonia by Inhaling Beclomethasone Propionate

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

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.

Study Overview

• Status: Unknown
• Conditions: Locally Advanced Non Small Cell Lung Cancer
• Intervention / Treatment: Drug: Beclomethasone propionate

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.

• Study Type: Interventional
• Enrollment (Anticipated): 194
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: caicun zhou, phD MD; Phone Number: 8621-65115006-3050; Email: caicunzhoudr@126.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Medical Department, Shanghai Pulmonary Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Prevention group; Participants inhaled beclomethasone propionate aerosol daily during chest radical radiotherapy (total dose 60GY).	Drug: Beclomethasone propionate; Beclomethasone propionate inhaled twice daily during radiotherapy
NO_INTERVENTION: Traditional therapy group; Participants were not given daily inhalation of beclomethasone propionate when undergoing radical chest radiotherapy (total dose 60GY).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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	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 .

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Tongji University
• Collaborators: Shanghai Pulmonary Hospital, Shanghai, China
• Investigators: Principal Investigator: caicun zhou, phD MD, Shanghai Pulmonary Hospital, Tongji University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2019
• Primary Completion (ANTICIPATED): September 30, 2020
• Study Completion (ANTICIPATED): December 30, 2020

Study Registration Dates

• First Submitted: March 14, 2019
• First Submitted That Met QC Criteria: March 20, 2019
• First Posted (ACTUAL): March 22, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 26, 2019
• Last Update Submitted That Met QC Criteria: March 23, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: NSCLC; radiation pneumonitis; beclomethasone propionate; radical radiotherapy; Preventive effect
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Beclomethasone
• Other Study ID Numbers: fk1416

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No