Trial Outcomes & Findings for Mitigation of Radiation Pneumonitis and Fibrosis (NCT NCT01754909)
NCT ID: NCT01754909
Last Updated: 2019-10-08
Results Overview
The clinical occurrence and grade of radiation pneumonitis, by National Cancer Institute Common Terminology Criteria Adverse Event grading ( NCI CTCAE)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
two years
Results posted on
2019-10-08
Participant Flow
50 consented
Verification of eligibility. Seven did not start study drug. Six of those because found ineligible after enrollment. One of those because of early termination of study.
Participant milestones
| Measure |
Enalapril
Use of enalapril in subjects undergoing radiotherapy for lung cancer.
Enalapril: Enalapril once a day, orally, as 2.5 , 5, or 10 mg tablets to be given in escalating doses, to subjects undergoing radiotherapy for lung cancer
|
Placebo
Use of placebo in subjects undergoing radiotherapy for lung cancer
placebo: Placebo, once a day, orally, as 2.5 , 5, or 10 mg tablets to be given in escalating doses, to subjects undergoing radiotherapy for lung cancer
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
23
|
|
Overall Study
COMPLETED
|
20
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Enalapril
n=20 Participants
Use of enalapril in subjects undergoing radiotherapy for lung cancer.
Enalapril: Enalapril once a day, orally, as 2.5 , 5, or 10 mg tablets to be given in escalating doses, to subjects undergoing radiotherapy for lung cancer
|
Placebo
n=23 Participants
Use of placebo in subjects undergoing radiotherapy for lung cancer
placebo: Placebo, once a day, orally, as 2.5 , 5, or 10 mg tablets to be given in escalating doses, to subjects undergoing radiotherapy for lung cancer
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=43 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=20 Participants
|
10 Participants
n=23 Participants
|
20 Participants
n=43 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=20 Participants
|
13 Participants
n=23 Participants
|
23 Participants
n=43 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=20 Participants
|
1 Participants
n=23 Participants
|
1 Participants
n=43 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=20 Participants
|
22 Participants
n=23 Participants
|
42 Participants
n=43 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
20 Participants
n=20 Participants
|
23 Participants
n=23 Participants
|
43 Participants
n=43 Participants
|
|
absence of pneumonitis or fibrosis
|
20 Participants
n=20 Participants
|
23 Participants
n=23 Participants
|
43 Participants
n=43 Participants
|
PRIMARY outcome
Timeframe: two yearsThe clinical occurrence and grade of radiation pneumonitis, by National Cancer Institute Common Terminology Criteria Adverse Event grading ( NCI CTCAE)
Outcome measures
| Measure |
Enalapril
n=20 Participants
Use of enalapril in subjects undergoing radiotherapy for lung cancer.
Enalapril: Enalapril once a day, orally, as 2.5 , 5, or 10 mg tablets to be given in escalating doses, to subjects undergoing radiotherapy for lung cancer
|
Placebo
n=23 Participants
Use of placebo in subjects undergoing radiotherapy for lung cancer
placebo: Placebo, once a day, orally, as 2.5 , 5, or 10 mg tablets to be given in escalating doses, to subjects undergoing radiotherapy for lung cancer
|
|---|---|---|
|
Number of Participants With Radiation Pneumonitis
|
8 participants
|
10 participants
|
SECONDARY outcome
Timeframe: six monthsPopulation: analyzed by CT scan readings done in a masked fashion
The occurrence and grade of radiation pneumonitis by radiographic criteria, using CT scanning
Outcome measures
| Measure |
Enalapril
n=20 Participants
Use of enalapril in subjects undergoing radiotherapy for lung cancer.
Enalapril: Enalapril once a day, orally, as 2.5 , 5, or 10 mg tablets to be given in escalating doses, to subjects undergoing radiotherapy for lung cancer
|
Placebo
n=21 Participants
Use of placebo in subjects undergoing radiotherapy for lung cancer
placebo: Placebo, once a day, orally, as 2.5 , 5, or 10 mg tablets to be given in escalating doses, to subjects undergoing radiotherapy for lung cancer
|
|---|---|---|
|
Number of Participants With Radiation Pneumonitis by CT Scan
|
16 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: one yearThe occurrence and grade of radiation fibrosis by radiographic criteria, using CT scanning
Outcome measures
| Measure |
Enalapril
n=20 Participants
Use of enalapril in subjects undergoing radiotherapy for lung cancer.
Enalapril: Enalapril once a day, orally, as 2.5 , 5, or 10 mg tablets to be given in escalating doses, to subjects undergoing radiotherapy for lung cancer
|
Placebo
n=23 Participants
Use of placebo in subjects undergoing radiotherapy for lung cancer
placebo: Placebo, once a day, orally, as 2.5 , 5, or 10 mg tablets to be given in escalating doses, to subjects undergoing radiotherapy for lung cancer
|
|---|---|---|
|
Number of Participants With Radiation Fibrosis
|
8 participants
|
4 participants
|
Adverse Events
Enalapril
Serious events: 9 serious events
Other events: 7 other events
Deaths: 11 deaths
Placebo
Serious events: 11 serious events
Other events: 8 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Enalapril
n=20 participants at risk
Use of enalapril in subjects undergoing radiotherapy for lung cancer.
Enalapril: Enalapril once a day, orally, as 2.5 , 5, or 10 mg tablets to be given in escalating doses, to subjects undergoing radiotherapy for lung cancer
|
Placebo
n=23 participants at risk
Use of placebo in subjects undergoing radiotherapy for lung cancer
placebo: Placebo, once a day, orally, as 2.5 , 5, or 10 mg tablets to be given in escalating doses, to subjects undergoing radiotherapy for lung cancer
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
death or hospitalization
|
45.0%
9/20 • Number of events 9 • lifetime of subject or until study end April 2018, an average of 2 years
Hospitalization or death
|
47.8%
11/23 • Number of events 11 • lifetime of subject or until study end April 2018, an average of 2 years
Hospitalization or death
|
Other adverse events
| Measure |
Enalapril
n=20 participants at risk
Use of enalapril in subjects undergoing radiotherapy for lung cancer.
Enalapril: Enalapril once a day, orally, as 2.5 , 5, or 10 mg tablets to be given in escalating doses, to subjects undergoing radiotherapy for lung cancer
|
Placebo
n=23 participants at risk
Use of placebo in subjects undergoing radiotherapy for lung cancer
placebo: Placebo, once a day, orally, as 2.5 , 5, or 10 mg tablets to be given in escalating doses, to subjects undergoing radiotherapy for lung cancer
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
hospitalization
|
35.0%
7/20 • lifetime of subject or until study end April 2018, an average of 2 years
Hospitalization or death
|
34.8%
8/23 • lifetime of subject or until study end April 2018, an average of 2 years
Hospitalization or death
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place