Trial Outcomes & Findings for Stereotactic Body Radiation Therapy (SBRT) in Metastatic Non-small Cell Lung Cancer (NCT NCT01185639)

Results Overview

Actuarial progression-free survival will be determined using the product-limit method of Kaplan and Meier and will be reported with an exact 95% confidence interval. Using the RECIST criteria including progression of the protocol treated tumors, non-protocol treated tumors and the development of new metastatic disease. Only protocol treated tumors will be determined by RECIST defined as complete lesion disappearance or \<25%or original size; partial \>30% decrease of target lesion; stable \<30% decreased of target lesion and; local failure increase \>20% of target lesion. Non-protocol tumor progression will be determined by the treating physician. Measured by imaging every 3 months.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

29 participants

Primary outcome timeframe

up to 2 years

Results posted on

2019-11-29

Participant Flow

Participant milestones

Participant milestones
Measure	SBRT for Metastatic NSCLC SBRT for lung lesions, liver lesions, adrenal lesions, spinal lesions stereotactic body radiation therapy: For lung, liver, axial skeleton, and adrenal tumors a dose of either 54 Gy in 3 fxs or 5000 cGy in 5 fx using SBRT techniques
Overall Study STARTED	29
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	SBRT for Metastatic NSCLC SBRT for lung lesions, liver lesions, adrenal lesions, spinal lesions stereotactic body radiation therapy: For lung, liver, axial skeleton, and adrenal tumors a dose of either 54 Gy in 3 fxs or 5000 cGy in 5 fx using SBRT techniques
Overall Study Progressed and didn't receive therapy	2

Baseline Characteristics

Stereotactic Body Radiation Therapy (SBRT) in Metastatic Non-small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SBRT for Metastatic NSCLC n=27 Participants SBRT for lung lesions, liver lesions, adrenal lesions, spinal lesions stereotactic body radiation therapy: For lung, liver, axial skeleton, and adrenal tumors a dose of either 54 Gy in 3 fxs or 5000 cGy in 5 fx using SBRT techniques
Age, Continuous	65 years n=39 Participants
Sex: Female, Male Female	11 Participants n=39 Participants
Sex: Female, Male Male	16 Participants n=39 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants
Race (NIH/OMB) Asian	0 Participants n=39 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants
Race (NIH/OMB) Black or African American	1 Participants n=39 Participants
Race (NIH/OMB) White	26 Participants n=39 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants

PRIMARY outcome

Timeframe: up to 2 years

Actuarial progression-free survival will be determined using the product-limit method of Kaplan and Meier and will be reported with an exact 95% confidence interval. Using the RECIST criteria including progression of the protocol treated tumors, non-protocol treated tumors and the development of new metastatic disease. Only protocol treated tumors will be determined by RECIST defined as complete lesion disappearance or \<25%or original size; partial \>30% decrease of target lesion; stable \<30% decreased of target lesion and; local failure increase \>20% of target lesion. Non-protocol tumor progression will be determined by the treating physician. Measured by imaging every 3 months.

Outcome measures

Outcome measures
Measure	SBRT for Metastatic NSCLC n=27 Participants SBRT for lung lesions, liver lesions, adrenal lesions, spinal lesions stereotactic body radiation therapy: For lung, liver, axial skeleton, and adrenal tumors a dose of either 54 Gy in 3 fxs or 5000 cGy in 5 fx using SBRT techniques
Progression-free Survival	11.2 months Interval 7.6 to 15.9

SECONDARY outcome

Timeframe: up to 3 months after treatment

Using the Vulnerable Elders Survey (VES-13) A 13-item self-reporting questionnaire includes age, self-rated health, limitations in physical function and disability to assess for deterioration of physical function/health. Scoring for the VES-13 is as follows: Total scores are summed together based on self-rated health (0-1), physical function (0-2), functional disability (0-4), (range from 0 to 7). A total score of 3 or more identifies participants as vulnerable to the risk of decline of physical function.

Outcome measures

Outcome measures
Measure	SBRT for Metastatic NSCLC n=27 Participants SBRT for lung lesions, liver lesions, adrenal lesions, spinal lesions stereotactic body radiation therapy: For lung, liver, axial skeleton, and adrenal tumors a dose of either 54 Gy in 3 fxs or 5000 cGy in 5 fx using SBRT techniques
To Assess Physical Function for This Cohort of Patients	2 Score on a scale Standard Deviation 2.7

SECONDARY outcome

Timeframe: up to 2 years

Local control (LC) of SBRT-treated lesions will only be assessed in patients with at least 4-months of radiographic follow-up.

Outcome measures

Outcome measures
Measure	SBRT for Metastatic NSCLC n=27 Participants SBRT for lung lesions, liver lesions, adrenal lesions, spinal lesions stereotactic body radiation therapy: For lung, liver, axial skeleton, and adrenal tumors a dose of either 54 Gy in 3 fxs or 5000 cGy in 5 fx using SBRT techniques
Number of Participants With Local Control	1 Participants

SECONDARY outcome

Timeframe: up to 4 years

Overall survival will be reported with an exact 95% confidence interval.

Outcome measures

Outcome measures
Measure	SBRT for Metastatic NSCLC n=27 Participants SBRT for lung lesions, liver lesions, adrenal lesions, spinal lesions stereotactic body radiation therapy: For lung, liver, axial skeleton, and adrenal tumors a dose of either 54 Gy in 3 fxs or 5000 cGy in 5 fx using SBRT techniques
Overall Survival	28.4 months Interval 14.5 to 45.8

SECONDARY outcome

Timeframe: up to 3 months after treatment

Using the Functional Assessment of Cancer Therapy - Lung (FACT-L) a 36-item self-administered questionnaire evaluating physical, social/family, emotional, and functional well-being; subscales (symptoms, cognitive function, regret of smoking) on a five-point scale from 0 (not at all) to 4 (very much). Maximum score 136. Subscale scores added to obtain total score. The higher the score the greater the impact on the quality of life.

Outcome measures

Outcome measures
Measure	SBRT for Metastatic NSCLC n=27 Participants SBRT for lung lesions, liver lesions, adrenal lesions, spinal lesions stereotactic body radiation therapy: For lung, liver, axial skeleton, and adrenal tumors a dose of either 54 Gy in 3 fxs or 5000 cGy in 5 fx using SBRT techniques
Impact of Treatment on Quality of Life (FACT-L)	100.3 score on a scale Standard Deviation 23.7

Adverse Events

SBRT for Metastatic NSCLC

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	SBRT for Metastatic NSCLC n=27 participants at risk SBRT for lung lesions, liver lesions, adrenal lesions, spinal lesions stereotactic body radiation therapy: For lung, liver, axial skeleton, and adrenal tumors a dose of either 54 Gy in 3 fxs or 5000 cGy in 5 fx using SBRT techniques
Injury, poisoning and procedural complications Rib fracture	3.7% 1/27 • Number of events 1 • 90 days following the end of radiation therapy will be recorded and graded on the AE Log. Only those toxicities Grade 3 and above will be reported. Only Grade 3 or higher adverse events that were possibly related to stereotactic body radiation therapy were collected for this study.

Additional Information

Dr. William Blackstock

Wake Forest University Health Sciences

Phone: 336-713-6501

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place