- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03886441
Prevention of Locally Advanced NSCLC Radiotherapy Pneumonia by Inhaling Beclomethasone Propionate
March 23, 2019 updated by: Caicun Zhou, Tongji University
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: caicun zhou, phD MD
- Phone Number: 8621-65115006-3050
- Email: caicunzhoudr@126.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200433
- Medical Department, Shanghai Pulmonary Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Prevention group
Participants inhaled beclomethasone propionate aerosol daily during chest radical radiotherapy (total dose 60GY).
|
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
Time Frame: Chest CT assessment every 6 weeks since thoracic irradiation, up to 36 weeks.
|
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
Time Frame: tumor assessment every 6 weeks since thoracic irradiation , up to 36 weeks.
|
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
Time Frame: 36 weeks .
|
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
Time Frame: 36 weeks
|
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
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: caicun zhou, phD MD, Shanghai Pulmonary Hospital, Tongji University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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