Trial Outcomes & Findings for Pre-operative Stereotactic Radiosurgery Followed by Resection for Brain Metastases (NCT NCT02514915)

NCT ID: NCT02514915

Last Updated: 2025-06-26

Results Overview

The probability that patients experience a change in size of a tumor (measured by the amount of space taken up by the tumor). Tumor volume was measured at 6 months compared to the tumor volume at the start of radiotherapy.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 24 participants
• Primary outcome timeframe: At 6 months
• Results posted on: 2025-06-26

Participant Flow

Participant milestones

Measure	Stereotactic Radiosurgery Subjects will receive stereotactic radiosurgery prior to resection Stereotactic Radiosurgery: Radiation therapy
Overall Study STARTED	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pre-operative Stereotactic Radiosurgery Followed by Resection for Brain Metastases

Baseline characteristics by cohort

Measure	Stereotactic Radiosurgery n=24 Participants Subjects will receive stereotactic radiosurgery prior to resection Stereotactic Radiosurgery: Radiation therapy
Age, Continuous	65.33333 years STANDARD_DEVIATION 8.6359 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: At 6 months

Population: All patients who received radiotherapy.

The probability that patients experience a change in size of a tumor (measured by the amount of space taken up by the tumor). Tumor volume was measured at 6 months compared to the tumor volume at the start of radiotherapy.

Outcome measures

Measure	Stereotactic Radiosurgery n=16 Participants Subjects will receive stereotactic radiosurgery prior to resection Stereotactic Radiosurgery: Radiation therapy
Local Control Rate (LCR) at 6 Months	0.817 proportion of patients Interval 0.669 to 0.997

PRIMARY outcome

Timeframe: At 12 months

Population: All patients who received radiotherapy.

The probability that patients experience a change in size of a tumor (measured by the amount of space taken up by the tumor). Tumor volume was measured at 12 months compared to the tumor volume at the start of radiotherapy.

Outcome measures

Measure	Stereotactic Radiosurgery n=15 Participants Subjects will receive stereotactic radiosurgery prior to resection Stereotactic Radiosurgery: Radiation therapy
Local Control Rate (LCR) at 12 Months	0.817 proportion of patients Interval 0.669 to 0.997

PRIMARY outcome

Timeframe: At 24 months

Population: All patients who received radiotherapy.

The probability that patients experience a change in size of a tumor (measured by the amount of space taken up by the tumor). Tumor volume was measured at 24 months compared to the tumor volume at the start of radiotherapy.

Outcome measures

Measure	Stereotactic Radiosurgery n=12 Participants Subjects will receive stereotactic radiosurgery prior to resection Stereotactic Radiosurgery: Radiation therapy
Local Control Rate (LCR) at 24 Months	0.749 proportion of patients Interval 0.579 to 0.973

SECONDARY outcome

Timeframe: At 6 months

Population: All patients who received radiotherapy.

The probability of patients being alive at 6 months after the beginning of treatment.

Outcome measures

Measure	Stereotactic Radiosurgery n=17 Participants Subjects will receive stereotactic radiosurgery prior to resection Stereotactic Radiosurgery: Radiation therapy
6-month Overall Survival (OS)	0.708 proportion of patients Interval 0.548 to 0.916

SECONDARY outcome

Timeframe: At 12 months

Population: All patients who received radiotherapy.

The probability of patients being alive at 12 months after the beginning of treatment.

Outcome measures

Measure	Stereotactic Radiosurgery n=15 Participants Subjects will receive stereotactic radiosurgery prior to resection Stereotactic Radiosurgery: Radiation therapy
12-month Overall Survival (OS)	0.625 proportion of patients Interval 0.458 to 0.852

SECONDARY outcome

Timeframe: At 24 months

Population: All patients who received radiotherapy.

The probability of patients being alive at 24 months after the beginning of treatment.

Outcome measures

Measure	Stereotactic Radiosurgery n=12 Participants Subjects will receive stereotactic radiosurgery prior to resection Stereotactic Radiosurgery: Radiation therapy
24-month Overall Survival (OS)	0.500 proportion of patients Interval 0.335 to 0.746

SECONDARY outcome

Timeframe: At 6 months

Population: All patients who received radiotherapy.

The probability of new brain metastases at 6 months identified via magnetic resonance imaging.

Outcome measures

Measure	Stereotactic Radiosurgery n=12 Participants Subjects will receive stereotactic radiosurgery prior to resection Stereotactic Radiosurgery: Radiation therapy
Distant Intracranial Failure	0.689 proportion of patients Interval 0.521 to 0.912

SECONDARY outcome

Timeframe: At 12 months

Population: All patients who received radiotherapy.

The probability of new brain metastases at 12 months identified via magnetic resonance imaging.

Outcome measures

Measure	Stereotactic Radiosurgery n=11 Participants Subjects will receive stereotactic radiosurgery prior to resection Stereotactic Radiosurgery: Radiation therapy
Distant Intracranial Failure	0.632 proportion of patients Interval 0.455 to 0.877

SECONDARY outcome

Timeframe: At 24 months

Population: All patients who received radiotherapy.

The probability of new brain metastases at 24 months identified via magnetic resonance imaging.

Outcome measures

Measure	Stereotactic Radiosurgery n=8 Participants Subjects will receive stereotactic radiosurgery prior to resection Stereotactic Radiosurgery: Radiation therapy
Distant Intracranial Failure	0.502 proportion of patients Interval 0.317 to 0.796

SECONDARY outcome

Timeframe: At 6 months (1.5-month window)

Population: All patients who received radiotherapy and completed required surveys.

The Functional Assessment of Cancer Therapy - Brain (FACT-Br) (23 questions that assess brain-tumor related issues) including the FACT-General (FACT-G), a core questionnaire used to determine the more general domains of QOL among all cancer patients was administered. This assessment is a 50 item, self-administered questionnaire used to assess Quality of Life, including, Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. Subscale scores range from 0-4. FACT-G = (PWB - 7 items, score range 0-28) + (SWB - 7 items, score range 0-28) + (EWB - 6 items, score 0-24) + (FWB - 7 items, 0-28). The assessment takes 10-15 minutes to completed and is scored using a 5-point Likert-type scale. FACT Gen Scores range from 0-108. Brain (FACT-Br) Scores range from 0-92 (23 questions with 0-4 score). Thus, total assessments combine scores range from 0-200. Higher total scores indicating better quality of life.

Outcome measures

Measure	Stereotactic Radiosurgery n=5 Participants Subjects will receive stereotactic radiosurgery prior to resection Stereotactic Radiosurgery: Radiation therapy
Health Related Quality of Life (HRQL) - FACT - BR (FACT - BRAIN)	139.878 score on a scale Standard Deviation 20.59528024

SECONDARY outcome

Timeframe: At 6 months (3-month window)

Population: All patients who received radiotherapy and completed required surveys.

The Functional Assessment of Cancer Therapy - Brain (FACT-Br) (23 questions that assess brain-tumor related issues) including the FACT-General (FACT-G), a core questionnaire used to determine the more general domains of QOL among all cancer patients was administered. This assessment is a 50 item, self-administered questionnaire used to assess Quality of Life, including, Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. Subscale scores range from 0-4. FACT-G = (PWB - 7 items, score range 0-28) + (SWB - 7 items, score range 0-28) + (EWB - 6 items, score 0-24) + (FWB - 7 items, 0-28). The assessment takes 10-15 minutes to completed and is scored using a 5-point Likert-type scale. FACT Gen Scores range from 0-108. Brain (FACT-Br) Scores range from 0-92 (23 questions with 0-4 score). Thus, total assessments combine scores range from 0-200. Higher total scores indicating better quality of life.

Outcome measures

Measure	Stereotactic Radiosurgery n=11 Participants Subjects will receive stereotactic radiosurgery prior to resection Stereotactic Radiosurgery: Radiation therapy
Health Related Quality of Life (HRQL) - FACT - BR (FACT - BRAIN)	142.1581538 score on a scale Standard Deviation 23.8429411

SECONDARY outcome

Timeframe: At 12 months (1.5-month window)

Population: All patients who received radiotherapy and completed required surveys.

The Functional Assessment of Cancer Therapy - Brain (FACT-Br) (23 questions that assess brain-tumor related issues) including the FACT-General (FACT-G), a core questionnaire used to determine the more general domains of QOL among all cancer patients was administered. This assessment is a 50 item, self-administered questionnaire used to assess Quality of Life, including, Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. Subscale scores range from 0-4. FACT-G = (PWB - 7 items, score range 0-28) + (SWB - 7 items, score range 0-28) + (EWB - 6 items, score 0-24) + (FWB - 7 items, 0-28). The assessment takes 10-15 minutes to completed and is scored using a 5-point Likert-type scale. FACT Gen Scores range from 0-108. Brain (FACT-Br) Scores range from 0-92 (23 questions with 0-4 score). Thus, total assessments combine scores range from 0-200. Higher total scores indicating better quality of life.

Outcome measures

Measure	Stereotactic Radiosurgery n=6 Participants Subjects will receive stereotactic radiosurgery prior to resection Stereotactic Radiosurgery: Radiation therapy
Health Related Quality of Life (HRQL) - FACT - BR (FACT - BRAIN)	141.0952857 score on a scale Standard Deviation 26.95376082

SECONDARY outcome

Timeframe: At 12 months (3-month window)

Population: All patients who received radiotherapy and completed required surveys.

The Functional Assessment of Cancer Therapy - Brain (FACT-Br) (23 questions that assess brain-tumor related issues) including the FACT-General (FACT-G), a core questionnaire used to determine the more general domains of QOL among all cancer patients was administered. This assessment is a 50 item, self-administered questionnaire used to assess Quality of Life, including, Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. Subscale scores range from 0-4. FACT-G = (PWB - 7 items, score range 0-28) + (SWB - 7 items, score range 0-28) + (EWB - 6 items, score 0-24) + (FWB - 7 items, 0-28). The assessment takes 10-15 minutes to completed and is scored using a 5-point Likert-type scale. FACT Gen Scores range from 0-108. Brain (FACT-Br) Scores range from 0-92 (23 questions with 0-4 score). Thus, total assessments combine scores range from 0-200. Higher total scores indicating better quality of life.

Outcome measures

Measure	Stereotactic Radiosurgery n=7 Participants Subjects will receive stereotactic radiosurgery prior to resection Stereotactic Radiosurgery: Radiation therapy
Health Related Quality of Life (HRQL) - FACT - BR (FACT - BRAIN)	143.3974615 score on a scale Standard Deviation 23.28519091

SECONDARY outcome

Timeframe: At 24 months (1.5-month window)

Population: All patients who received radiotherapy and completed required surveys.

The Functional Assessment of Cancer Therapy - Brain (FACT-Br) (23 questions that assess brain-tumor related issues) including the FACT-General (FACT-G), a core questionnaire used to determine the more general domains of QOL among all cancer patients was administered. This assessment is a 50 item, self-administered questionnaire used to assess Quality of Life, including, Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. Subscale scores range from 0-4. FACT-G = (PWB - 7 items, score range 0-28) + (SWB - 7 items, score range 0-28) + (EWB - 6 items, score 0-24) + (FWB - 7 items, 0-28). The assessment takes 10-15 minutes to completed and is scored using a 5-point Likert-type scale. FACT Gen Scores range from 0-108. Brain (FACT-Br) Scores range from 0-92 (23 questions with 0-4 score). Thus, total assessments combine scores range from 0-200. Higher total scores indicating better quality of life..

Outcome measures

Measure	Stereotactic Radiosurgery n=1 Participants Subjects will receive stereotactic radiosurgery prior to resection Stereotactic Radiosurgery: Radiation therapy
Health Related Quality of Life (HRQL) - FACT - BR (FACT - BRAIN)	167 score on a scale Standard Deviation NA Single participant score; no SD

SECONDARY outcome

Timeframe: At 24 months (3-month window)

Population: All patients who received radiotherapy and completed required surveys.

The Functional Assessment of Cancer Therapy - Brain (FACT-Br) (23 questions that assess brain-tumor related issues) including the FACT-General (FACT-G), a core questionnaire used to determine the more general domains of QOL among all cancer patients was administered. This assessment is a 50 item, self-administered questionnaire used to assess Quality of Life, including, Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. Subscale scores range from 0-4. FACT-G = (PWB - 7 items, score range 0-28) + (SWB - 7 items, score range 0-28) + (EWB - 6 items, score 0-24) + (FWB - 7 items, 0-28). The assessment takes 10-15 minutes to completed and is scored using a 5-point Likert-type scale. FACT Gen Scores range from 0-108. Brain (FACT-Br) Scores range from 0-92 (23 questions with 0-4 score). Thus, total assessments combine scores range from 0-200. Higher total scores indicating better quality of life.

Outcome measures

Measure	Stereotactic Radiosurgery n=5 Participants Subjects will receive stereotactic radiosurgery prior to resection Stereotactic Radiosurgery: Radiation therapy
Health Related Quality of Life (HRQL) - FACT - BR (FACT - BRAIN)	150.1484545 score on a scale Standard Deviation 23.94648714

Adverse Events

Stereotactic Radiosurgery

Serious events: 0 serious events

Other events: 0 other events

Deaths: 19 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Barbara Stadterman, MPH, CCRP, Clinical Research Manager

UPMC Hillman Cancer Center

Phone: 4126233272

Email: stadtermanbm@upmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place