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

Recruitment status

TERMINATED

Study phase

Target enrollment

3 participants

Primary outcome timeframe

2 years

Results posted on

2021-01-22

Participant Flow

Participant milestones

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

PRIMARY outcome

Timeframe: 2 years

Population: 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 years

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

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

B - 12 Gy x 5 Daily Fractions

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

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

Phone: 304-293-0216

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

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=5 Participants	—	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	—	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	—	2 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	—	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	—	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	—	3 participants n=5 Participants