Trial Outcomes & Findings for Phase II Image Guided Stereotactic Ablative Radiotherapy for Non-Small Cell Lung Cancer (NCT NCT02262000)
NCT ID: NCT02262000
Last Updated: 2021-01-22
Results Overview
TERMINATED
NA
3 participants
2 years
2021-01-22
Participant Flow
Participant milestones
| Measure |
A - 7.5 Gy x 10 Daily Fractions
Radiotherapy: 7.5 Gy x 10 daily fractions delivered with volumetric modulated arc therapy (VMAT) or regular intensity-modulated radiation therapy (IMRT) at West Virginia University.
Image Guided Stereotactic Ablative Radiotherapy
|
B - 12 Gy x 5 Daily Fractions
Radiotherapy: Optional schedule of 12 Gy x 5 daily fractions can may also be used ONLY in situations where dose constraints for organs at risk can be EASILY met while optimal planning target volume (PTV) coverage is achieved
Image Guided Stereotactic Ablative Radiotherapy
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
0
|
|
Overall Study
COMPLETED
|
3
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Image Guided Stereotactic Ablative Radiotherapy for Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
A - 7.5 Gy x 10 Daily Fractions
n=3 Participants
Radiotherapy: 7.5 Gy x 10 daily fractions delivered with VMAT or regular IMRT at West Virginia University.
Image Guided Stereotactic Ablative Radiotherapy
|
B - 12 Gy x 5 Daily Fractions
Radiotherapy: Optional schedule of 12 Gy x 5 daily fractions can may also be used ONLY in situations where dose constraints for organs at risk can be EASILY met while optimal PTV coverage is achieved
Image Guided Stereotactic Ablative Radiotherapy
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
—
|
3 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
—
|
2 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=99 Participants
|
—
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants
|
—
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=99 Participants
|
—
|
3 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Data is not available because the study was terminated and the original PI left the institution. All efforts were made to contact the PI/study team, but we were unsuccessful. No outcome measures data was available.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: Data is not available because the study was terminated and the original PI left the institution. All efforts were made to contact the PI/study team, but we were unsuccessful. No outcome measures data was available.
To determine the 2-year regional, and distant metastasis rates, progression-free survival (PFS), local progression free survival (L-PFS), overall survival (OS)
Outcome measures
Outcome data not reported
Adverse Events
A - 7.5 Gy x 10 Daily Fractions
B - 12 Gy x 5 Daily Fractions
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Clinical Trials Compliance Coordinator
West Virginia Universtiy, WVCTSI
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place