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Prevention of Locally Advanced NSCLC Radiotherapy Pneumonia by Inhaling Beclomethasone Propionate

Primary Purpose

Locally Advanced Non Small Cell Lung Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Beclomethasone propionate

About this trial

This is an interventional prevention trial for Locally Advanced Non Small Cell Lung Cancer focused on measuring beclomethasone propionate, radiation pneumonitis, NSCLC, radical radiotherapy, Preventive effect

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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

Sites / Locations

Medical Department, Shanghai Pulmonary Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Prevention group

Traditional therapy group

Arm Description

Participants inhaled beclomethasone propionate aerosol daily during chest radical radiotherapy (total dose 60GY).

Participants were not given daily inhalation of beclomethasone propionate when undergoing radical chest radiotherapy (total dose 60GY).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Objective Response Rate between two groups of patients

To evaluate Objective response rate every 6weeks since thoracic irradiation.

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

Full Information

NCT ID

NCT03886441

First Posted

March 14, 2019

Last Updated

March 23, 2019

Sponsor

Tongji University

Collaborators

Shanghai Pulmonary Hospital, Shanghai, China

1. Study Identification

Unique Protocol Identification Number

NCT03886441

Brief Title

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

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Unknown status

Study Start Date

April 1, 2019 (Anticipated)

Primary Completion Date

September 30, 2020 (Anticipated)

Study Completion Date

December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tongji University

Collaborators

Shanghai Pulmonary Hospital, Shanghai, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Locally Advanced Non Small Cell Lung Cancer

Keywords

beclomethasone propionate, radiation pneumonitis, NSCLC, radical radiotherapy, Preventive effect

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

194 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Prevention group

Arm Type

Experimental

Arm Description

Participants inhaled beclomethasone propionate aerosol daily during chest radical radiotherapy (total dose 60GY).

Arm Title

Traditional therapy group

Arm Type

No Intervention

Arm Description

Participants were not given daily inhalation of beclomethasone propionate when undergoing radical chest radiotherapy (total dose 60GY).

Intervention Type

Drug

Intervention Name(s)

Beclomethasone propionate

Intervention Description

Beclomethasone propionate inhaled twice daily during radiotherapy

Primary Outcome Measure Information:

Title

Incidence of radiation pneumonia between two groups of patients

Description

To evaluate the incidence of radiation pneumonia in 36weeks since thoracic irradiation between two groups of patients

Time Frame

Chest CT assessment every 6 weeks since thoracic irradiation, up to 36 weeks.

Secondary Outcome Measure Information:

Title

Objective Response Rate between two groups of patients

Description

To evaluate Objective response rate every 6weeks since thoracic irradiation.

Time Frame

tumor assessment every 6 weeks since thoracic irradiation , up to 36 weeks.

Title

Side effects between two groups of patients

Description

To evaluated in the 36 weeks since the thoracic irradiation began according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

Time Frame

36 weeks .

Other Pre-specified Outcome Measures:

Title

Quality of life between two groups of patients

Description

evaluated every 6 weeks since the thoracic irradiation began according to the EORTC Quality-of-Life Questionnarire-Lung Cancer 13 Module(EORTC OLO-LC13)

Time Frame

36 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

caicun zhou, phD MD

Phone

8621-65115006-3050

caicunzhoudr@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

jie zhang, MD

Phone

13501878890

zhangjie2172@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

caicun zhou, phD MD

Organizational Affiliation

Shanghai Pulmonary Hospital, Tongji University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical Department, Shanghai Pulmonary Hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200433

Country

China

12. IPD Sharing Statement

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Prevention of Locally Advanced NSCLC Radiotherapy Pneumonia by Inhaling Beclomethasone Propionate

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