Trial Outcomes & Findings for An Outcome Analysis for Stereotactic Body Radiation Therapy (SBRT) Treatment of Non-Small Lung Cancer Patients Using 4D PET/CT With Real-Time Position Management (RPM™) System and a Concomitant Evaluation of the Impact and Performance Characteristics of the Immobilization System (NCT NCT02067858)

Results Overview

The Number of Patients that completed SBRT

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

6 participants

Primary outcome timeframe

2 years

Results posted on

2018-07-18

Participant Flow

Participant milestones

Participant milestones
Measure	Stereotactic Radiosurgery 3 fractions x 20 Gy 4 fractions x 12 Gy Lesion dependent Stereotactic Radiosurgery
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Outcome Analysis for Stereotactic Body Radiation Therapy (SBRT) Treatment of Non-Small Lung Cancer Patients Using 4D PET/CT With Real-Time Position Management (RPM™) System and a Concomitant Evaluation of the Impact and Performance Characteristics of the Immobilization System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stereotactic Radiosurgery n=6 Participants 3 fractions x 20 Gy 4 fractions x 12 Gy Lesion dependent Stereotactic Radiosurgery
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

The Number of Patients that completed SBRT

Outcome measures

Outcome measures
Measure	Stereotactic Radiosurgery n=6 Participants 3 fractions x 20 Gy 4 fractions x 12 Gy Lesion dependent Stereotactic Radiosurgery
Assess Clinical Response Rate and Local Control Following SBRT Treatment of Patients With Early Stage NSCLC	4 Participants

SECONDARY outcome

Timeframe: 2 years

Number of patients with Progression Free Survival at 2 Years

Outcome measures

Outcome measures
Measure	Stereotactic Radiosurgery n=3 Participants 3 fractions x 20 Gy 4 fractions x 12 Gy Lesion dependent Stereotactic Radiosurgery
Assess Progression-free Survival	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

Population: Blood draw samples were not drawn nor analyzed for this study

Research blood draws looking at imaging repsonse before and after radiation in relationship to serum protein and peptide profiles

Outcome measures

Outcome data not reported

Adverse Events

Stereotactic Radiosurgery

Serious events: 0 serious events

Other events: 0 other events

Deaths: 5 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Karen Holeva

University of Pittsburgh

Phone: 412-623-1275

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place