Trial · NCT01754909
Mitigation of Radiation Pneumonitis and Fibrosis
NCT01754909, Phase 2, Completed, VA Office of Research and Development; results first posted 2019-10-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Mitigation of Radiation Pneumonitis and Fibrosis. Trials, record NCT01754909. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01754909
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Mitigation of Radiation Pneumonitis and Fibrosis
- NCT number
- NCT01754909
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 50 participants, actual
- Lead sponsor
- VA Office of Research and Development
- Conditions
- Lung Cancer, Radiation Pneumonitis
- Interventions
- Enalapril, placebo
- First posted
- 2012-12-21
- Last updated
- 2019-10-08
- Results first posted
- 2019-10-01
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Radiation Pneumonitis | two years | The clinical occurrence and grade of radiation pneumonitis, by National Cancer Institute Common Terminology Criteria Adverse Event grading ( NCI CTCAE) |
| Secondary | Number of Participants With Radiation Pneumonitis by CT Scan | six months | The occurrence and grade of radiation pneumonitis by radiographic criteria, using CT scanning |
| Secondary | Number of Participants With Radiation Fibrosis | one year | The occurrence and grade of radiation fibrosis by radiographic criteria, using CT scanning |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Radiation Pneumonitis | two years | participants | NUMBER | |
| SECONDARY | Number of Participants With Radiation Pneumonitis by CT Scan | six months | analyzed by CT scan readings done in a masked fashion | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Radiation Fibrosis | one year | participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Radiation Pneumonitis | Enalapril | 8 | participants | ||
| Number of Participants With Radiation Pneumonitis | Placebo | 10 | participants | ||
| Number of Participants With Radiation Pneumonitis by CT Scan | Enalapril | 16 | Participants | ||
| Number of Participants With Radiation Pneumonitis by CT Scan | Placebo | 12 | Participants | ||
| Number of Participants With Radiation Fibrosis | Enalapril | 8 | participants | ||
| Number of Participants With Radiation Fibrosis | Placebo | 4 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Enalapril | 20 | |
| Overall Study | STARTED | Placebo | 23 | |
| Overall Study | COMPLETED | Enalapril | 20 | |
| Overall Study | COMPLETED | Placebo | 23 | |
| Overall Study | NOT COMPLETED | Enalapril | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | hospitalization | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Enalapril | 7 | 20 | |
| other | hospitalization | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Placebo | 8 | 23 | |
| serious | death or hospitalization | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Enalapril | 9 | 20 | 9 |
| serious | death or hospitalization | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Placebo | 11 | 23 | 11 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Enalapril | 11 | 20 |
| Total, all-cause mortality | Placebo | 7 | 23 |
| Total, other adverse events | Enalapril | 7 | 20 |
| Total, other adverse events | Placebo | 8 | 23 |
| Total, serious adverse events | Enalapril | 9 | 20 |
| Total, serious adverse events | Placebo | 11 | 23 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| I01CX000569 | Mitigation of Radiation Pneumonitis and Fibrosis | COHEN, ERIC PHIN | BALTIMORE VA MEDICAL CENTER | Veterans Affairs | 2013 to 2017 |
Source NIH RePORTER
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Enalapril vs Placebo: Number of Participants With Radiation Pneumonitis by CT Scan | Trial comparisons |
| Enalapril vs Placebo: Number of Participants With Radiation Pneumonitis | Trial comparisons |
| Enalapril vs Placebo: Number of Participants With Radiation Fibrosis | Trial comparisons |
| Enalapril vs Placebo: deaths from any cause | Trial comparisons |
| Enalapril vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01754909
GET https://conductscience.org/api/trials/v1/NCT01754909/registered