Locally Advanced Non Small Cell Lung CancerPhase 2NCT03886441
Prevention of Locally Advanced NSCLC Radiotherapy Pneumonia by Inhaling Beclomethasone Propionate
A Phase 2 study testing Beclomethasone propionate in people with Locally Advanced Non Small Cell Lung Cancer, run by Tongji University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Locally Advanced Non Small Cell Lung Cancer
- What is being tested?
- Beclomethasone propionate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2019to 30 Dec 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Adequate hematologic function:
- Peripheral blood neutrophil count > 2000 cells / uL, Platelet count > 100109 / 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Medical Department, Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
About this study
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
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.
Read the 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.
- Being tested
- Beclomethasone propionate
- Keywords
- beclomethasone propionate, radiation pneumonitis, NSCLC, radical radiotherapy, Preventive effect
- Medical subject headings
- Radiation Pneumonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beclomethasone propionateDrug
Beclomethasone propionate inhaled twice daily during radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Prevention group | Experimental | Participants inhaled beclomethasone propionate aerosol daily during chest radical radiotherapy (total dose 60GY). Receives: Drug: Beclomethasone propionate |
| Traditional therapy group | No intervention | Participants were not given daily inhalation of beclomethasone propionate when undergoing radical chest radiotherapy (total dose 60GY). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Chest CT assessment every 6 weeks since thoracic irradiation, up to 36 weeks.
Secondary outcomes (2)
Objective Response Rate between two groups of patients
To evaluate Objective response rate every 6weeks since thoracic irradiation.
Measured: 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
Measured: 36 weeks .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2019
- Study start1 Apr 2019 (estimated)
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Pulmonary Hospital, Shanghai, China
- Responsible party
- Principal investigator, Caicun Zhou, Tongji University
- Investigators
- caicun zhou, phD MD, Principal investigator, Shanghai Pulmonary Hospital, Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03886441
- Sponsor's protocol ID
- fk1416
- Status last verified
- Mar 2019
- First submitted
- 14 Mar 2019
- Last updated
- 26 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03886441
- Acronym / sponsor ID
- fk1416
- Keywords
- beclomethasone propionate, radiation pneumonitis, NSCLC, radical radiotherapy, Preventive effect
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- Tongji UniversityUniversity, hospital or other
- Collaborators
- Shanghai Pulmonary Hospital, Shanghai, China
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 22 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prevention group | Experimental | Drug: Beclomethasone propionateParticipants inhaled beclomethasone propionate aerosol daily during chest radical radiotherapy (total dose 60GY). |
| Traditional therapy group | No intervention | –Participants were not given daily inhalation of beclomethasone propionate when undergoing radical chest radiotherapy (total dose 60GY). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beclomethasone propionateBeclomethasone propionate inhaled twice daily during radiotherapy | Drug | Prevention group |
Primary outcome
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
2 secondary outcomes
Objective Response Rate between two groups of patients
Time frame: tumor assessment every 6 weeks since thoracic irradiation , up to 36 weeks.
Side effects between two groups of patients
Time frame: 36 weeks .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
caicun zhou, phD MD principal investigator
Shanghai Pulmonary Hospital, Tongji University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Beclomethasone propionate in people with Locally Advanced Non Small Cell Lung Cancer, run by Tongji University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact caicun zhou, phD MD (8621-65115006-3050, caicunzhoudr@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of radiation pneumonia between two groups of patients (time frame: Chest CT assessment every 6 weeks since thoracic irradiation, up to 36 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2019.