Trial Outcomes & Findings for Rapid Radiation Therapy for Painful Osseous Metastatic Disease (NCT NCT01391234)

Results Overview

The Brief Pain Inventory (BPI) and Oral Morphine Equivalent Doses (OMED) were used to categorize the number of participants who had a Complete Response (no pain), Partial Response (pain reduction), Stable Pain (no change in pain), and Pain Progression at 12 months after receiving treatment via the STAT RT workflow.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

28 participants

Primary outcome timeframe

12 months after treatment

Results posted on

2022-12-01

Participant Flow

28 Patients were prospectively enrolled on a pilot clinical trial between 2011 and 2014. Patients were required to have biopsy-proven cancer with 1-3 painful osseous metastases, recent diagnostic imaging demonstrating metastatic disease, and persistent distinguishable pain at the target site(s) with an average pain score of 3 or greater

Participant milestones

Participant milestones
Measure	STAT RT Planning and Delivery Workflow single arm STAT RT planning and delivery workflow: -Patients will receive simulation, planning, quality assurance, and their first treatment in a single day using the STAT RT workflow. * Patients will receive a total of 1-5 fractions of high dose palliative radiation therapy via TomoTherapy consisting of 5-10 Gray per fraction. * Data will be collected to evaluate the effectiveness of our novel image co-registration techniques, CT-detector-based exit dose calculations, and infrared patient position monitoring. These novel techniques for image co-registration, radiation dose calculations, and patient position monitoring will not alter or replace standard of care techniques.
Overall Study STARTED	28
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Rapid Radiation Therapy for Painful Osseous Metastatic Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	STAT RT Planning and Delivery Workflow n=28 Participants single arm STAT RT planning and delivery workflow: -Patients will receive simulation, planning, quality assurance, and their first treatment in a single day using the STAT RT workflow. * Patients will receive a total of 1-5 fractions of high dose palliative radiation therapy via TomoTherapy consisting of 5-10 Gray per fraction. * Data will be collected to evaluate the effectiveness of our novel image co-registration techniques, CT-detector-based exit dose calculations, and infrared patient position monitoring. These novel techniques for image co-registration, radiation dose calculations, and patient position monitoring will not alter or replace standard of care techniques.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=99 Participants
Age, Categorical >=65 years	10 Participants n=99 Participants
Sex: Female, Male Female	10 Participants n=99 Participants
Sex: Female, Male Male	18 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	2 Participants n=99 Participants
Race (NIH/OMB) White	26 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	28 participants n=99 Participants

PRIMARY outcome

Timeframe: 12 months after treatment

Population: The Brief Pain Inventory (BPI) and Oral Morphine Equivalent Doses (OMED) were used to categorize the number of participants who had a Complete Response (no pain), Partial Response (pain reduction), or Stable Pain (no change in pain) at 12 months after receiving treatment via the STAT RT workflow.

The Brief Pain Inventory (BPI) and Oral Morphine Equivalent Doses (OMED) were used to categorize the number of participants who had a Complete Response (no pain), Partial Response (pain reduction), Stable Pain (no change in pain), and Pain Progression at 12 months after receiving treatment via the STAT RT workflow.

Outcome measures

Outcome measures
Measure	STAT RT Planning and Delivery Workflow n=28 Participants single arm STAT RT planning and delivery workflow: -Patients will receive simulation, planning, quality assurance, and their first treatment in a single day using the STAT RT workflow. * Patients will receive a total of 1-5 fractions of high dose palliative radiation therapy via TomoTherapy consisting of 5-10 Gray per fraction. * Data will be collected to evaluate the effectiveness of our novel image co-registration techniques, CT-detector-based exit dose calculations, and infrared patient position monitoring. These novel techniques for image co-registration, radiation dose calculations, and patient position monitoring will not alter or replace standard of care techniques.
Number of Participants With a Complete Response, Partial Response, or Stable Pain After Receiving Treatment Via the STAT RT Workflow at 12-months	9 Participants

SECONDARY outcome

Timeframe: 12 months after treatment

Population: Number of subjects with Grade 3 or higher adverse events within 12 months after initial treatment. No serious AEs reported; all AEs were grade 2 or less. Additional AE details found in published article.

Toxicity will be assessed by CTCAE Version 4.0 Toxicity will be assessed up to 12 months after treatment.

Outcome measures

Outcome measures
Measure	STAT RT Planning and Delivery Workflow n=28 Participants single arm STAT RT planning and delivery workflow: -Patients will receive simulation, planning, quality assurance, and their first treatment in a single day using the STAT RT workflow. * Patients will receive a total of 1-5 fractions of high dose palliative radiation therapy via TomoTherapy consisting of 5-10 Gray per fraction. * Data will be collected to evaluate the effectiveness of our novel image co-registration techniques, CT-detector-based exit dose calculations, and infrared patient position monitoring. These novel techniques for image co-registration, radiation dose calculations, and patient position monitoring will not alter or replace standard of care techniques.
Number of Participants With Treatment Toxicity	0 participants

SECONDARY outcome

Timeframe: 1 Week Post Treatment

The patient's quality of life function will be assessed using the Brief Pain Inventory (BPI) 1 week post treatment. Min-'0'/'Does not interfere'; Max-'10'/'Completely interferes.' ; Worst Pain Score: 1-4=Mild Pain, Worst Pain Score 5-6=Moderate Pain. Worst Pain Score 7-10=Severe Pain.

Outcome measures

Outcome measures
Measure	STAT RT Planning and Delivery Workflow n=28 Participants single arm STAT RT planning and delivery workflow: -Patients will receive simulation, planning, quality assurance, and their first treatment in a single day using the STAT RT workflow. * Patients will receive a total of 1-5 fractions of high dose palliative radiation therapy via TomoTherapy consisting of 5-10 Gray per fraction. * Data will be collected to evaluate the effectiveness of our novel image co-registration techniques, CT-detector-based exit dose calculations, and infrared patient position monitoring. These novel techniques for image co-registration, radiation dose calculations, and patient position monitoring will not alter or replace standard of care techniques.
Number of Participants With an Improved Quality of Life Function Score at 1 Week Post Treatment	19 Participants

SECONDARY outcome

Timeframe: 4 weeks post treatment

The patient's quality of life and function will be assessed using the Brief Pain Inventory (BPI) 4 weeks post treatment. Min-'0'/'Does not interfere'; Max-'10'/'Completely interferes.' ; Worst Pain Score: 1-4=Mild Pain, Worst Pain Score 5-6=Moderate Pain. Worst Pain Score 7-10=Severe Pain.

Outcome measures

Outcome measures
Measure	STAT RT Planning and Delivery Workflow n=28 Participants single arm STAT RT planning and delivery workflow: -Patients will receive simulation, planning, quality assurance, and their first treatment in a single day using the STAT RT workflow. * Patients will receive a total of 1-5 fractions of high dose palliative radiation therapy via TomoTherapy consisting of 5-10 Gray per fraction. * Data will be collected to evaluate the effectiveness of our novel image co-registration techniques, CT-detector-based exit dose calculations, and infrared patient position monitoring. These novel techniques for image co-registration, radiation dose calculations, and patient position monitoring will not alter or replace standard of care techniques.
Number of Participants With an Improved Quality of Life Function Score at 4 Weeks After Initial Treatment	21 Participants

SECONDARY outcome

Timeframe: 8 weeks post initial treatment

The patient's quality of life function will be assessed using the Brief Pain Inventory (BPI) 8 weeks post treatment. Min-'0'/'Does not interfere'; Max-'10'/'Completely interferes.' ; Worst Pain Score: 1-4=Mild Pain, Worst Pain Score 5-6=Moderate Pain. Worst Pain Score 7-10=Severe Pain.

Outcome measures

Outcome measures
Measure	STAT RT Planning and Delivery Workflow n=28 Participants single arm STAT RT planning and delivery workflow: -Patients will receive simulation, planning, quality assurance, and their first treatment in a single day using the STAT RT workflow. * Patients will receive a total of 1-5 fractions of high dose palliative radiation therapy via TomoTherapy consisting of 5-10 Gray per fraction. * Data will be collected to evaluate the effectiveness of our novel image co-registration techniques, CT-detector-based exit dose calculations, and infrared patient position monitoring. These novel techniques for image co-registration, radiation dose calculations, and patient position monitoring will not alter or replace standard of care techniques.
Number of Participants With an Improved Quality of Life Function Score at 8 Weeks After Initial Treatment	15 Participants

SECONDARY outcome

Timeframe: 12 weeks post treatment.

The patient's quality of life and function will be assessed using the Brief Pain Inventory (BPI) 12 weeks post treatment. Min-'0'/'Does not interfere'; Max-'10'/'Completely interferes.' ; Worst Pain Score: 1-4=Mild Pain, Worst Pain Score 5-6=Moderate Pain. Worst Pain Score 7-10=Severe Pain.

Outcome measures

Outcome measures
Measure	STAT RT Planning and Delivery Workflow n=28 Participants single arm STAT RT planning and delivery workflow: -Patients will receive simulation, planning, quality assurance, and their first treatment in a single day using the STAT RT workflow. * Patients will receive a total of 1-5 fractions of high dose palliative radiation therapy via TomoTherapy consisting of 5-10 Gray per fraction. * Data will be collected to evaluate the effectiveness of our novel image co-registration techniques, CT-detector-based exit dose calculations, and infrared patient position monitoring. These novel techniques for image co-registration, radiation dose calculations, and patient position monitoring will not alter or replace standard of care techniques.
Number of Participants With an Improved Quality of Life Function Score at 12 Weeks Post Initial Treatment	15 Participants

SECONDARY outcome

Timeframe: 6 months post treatment

the patient's quality of life and function will be assessed using the Brief Pain Inventory (BPI) 6 months post treatment. Min-'0'/'Does not interfere'; Max-'10'/'Completely interferes.' ; Worst Pain Score: 1-4=Mild Pain, Worst Pain Score 5-6=Moderate Pain. Worst Pain Score 7-10=Severe Pain.

Outcome measures

Outcome measures
Measure	STAT RT Planning and Delivery Workflow n=28 Participants single arm STAT RT planning and delivery workflow: -Patients will receive simulation, planning, quality assurance, and their first treatment in a single day using the STAT RT workflow. * Patients will receive a total of 1-5 fractions of high dose palliative radiation therapy via TomoTherapy consisting of 5-10 Gray per fraction. * Data will be collected to evaluate the effectiveness of our novel image co-registration techniques, CT-detector-based exit dose calculations, and infrared patient position monitoring. These novel techniques for image co-registration, radiation dose calculations, and patient position monitoring will not alter or replace standard of care techniques.
Number of Participants With an Improved Quality of Life Function Score at 6 Months After Initial Treatment	13 Participants

SECONDARY outcome

Timeframe: 12 months post treatment

The patient's quality of life and function will be assessed using the Brief Pain Inventory (BPI) 12 months post treatment. Min-'0'/'Does not interfere'; Max-'10'/'Completely interferes.' ; Worst Pain Score: 1-4=Mild Pain, Worst Pain Score 5-6=Moderate Pain. Worst Pain Score 7-10=Severe Pain.

Outcome measures

Outcome measures
Measure	STAT RT Planning and Delivery Workflow n=28 Participants single arm STAT RT planning and delivery workflow: -Patients will receive simulation, planning, quality assurance, and their first treatment in a single day using the STAT RT workflow. * Patients will receive a total of 1-5 fractions of high dose palliative radiation therapy via TomoTherapy consisting of 5-10 Gray per fraction. * Data will be collected to evaluate the effectiveness of our novel image co-registration techniques, CT-detector-based exit dose calculations, and infrared patient position monitoring. These novel techniques for image co-registration, radiation dose calculations, and patient position monitoring will not alter or replace standard of care techniques.
Number of Participants With an Improved Quality of Life Function Score at 12 Months After Initial Treatment	10 Participants

SECONDARY outcome

Timeframe: 1 week post treatment

The patient's quality of life and function will be assessed using the Functional Assessment of Cancer Therapy (FACT-BP) survey 1 week post treatment. Min-'0'/'Not at all' and Maximum 4+ 'Very much.' Items scored per FACT\_BP Scoring guidelines version 4; Score Range 0-60; The higher the score, the better QOL function.

Outcome measures

Outcome measures
Measure	STAT RT Planning and Delivery Workflow n=28 Participants single arm STAT RT planning and delivery workflow: -Patients will receive simulation, planning, quality assurance, and their first treatment in a single day using the STAT RT workflow. * Patients will receive a total of 1-5 fractions of high dose palliative radiation therapy via TomoTherapy consisting of 5-10 Gray per fraction. * Data will be collected to evaluate the effectiveness of our novel image co-registration techniques, CT-detector-based exit dose calculations, and infrared patient position monitoring. These novel techniques for image co-registration, radiation dose calculations, and patient position monitoring will not alter or replace standard of care techniques.
Patient Quality of Life and Function (FACT-BP) Assessed 1 Week Post Initial Treatment	19 Participants

SECONDARY outcome

Timeframe: 4 weeks post treatment

The patient's quality of life and function will be assessed using the Functional Assessment of Cancer Therapy (FACT-BP) survey 4 weeks post treatment. Min-'0'/'Not at all' and Maximum 4+ 'Very much.' Items scored per FACT\_BP Scoring guidelines version 4; Score Range 0-60; The higher the score, the better QOL function.

Outcome measures

Outcome measures
Measure	STAT RT Planning and Delivery Workflow n=28 Participants single arm STAT RT planning and delivery workflow: -Patients will receive simulation, planning, quality assurance, and their first treatment in a single day using the STAT RT workflow. * Patients will receive a total of 1-5 fractions of high dose palliative radiation therapy via TomoTherapy consisting of 5-10 Gray per fraction. * Data will be collected to evaluate the effectiveness of our novel image co-registration techniques, CT-detector-based exit dose calculations, and infrared patient position monitoring. These novel techniques for image co-registration, radiation dose calculations, and patient position monitoring will not alter or replace standard of care techniques.
Patient Quality of Life and Function (FACT-BP) Assessed 4 Weeks After Initial Treatment	21 Participants

SECONDARY outcome

Timeframe: 8 weeks post treatment

The patient's quality of life and function will be assessed using the Functional Assessment of Cancer Therapy (FACT-BP) survey 8 weeks post treatment. Min-'0'/'Not at all' and Maximum 4+ 'Very much.' Items scored per FACT\_BP Scoring guidelines version 4; Score Range 0-60; The higher the score, the better QOL function.

Outcome measures

Outcome measures
Measure	STAT RT Planning and Delivery Workflow n=28 Participants single arm STAT RT planning and delivery workflow: -Patients will receive simulation, planning, quality assurance, and their first treatment in a single day using the STAT RT workflow. * Patients will receive a total of 1-5 fractions of high dose palliative radiation therapy via TomoTherapy consisting of 5-10 Gray per fraction. * Data will be collected to evaluate the effectiveness of our novel image co-registration techniques, CT-detector-based exit dose calculations, and infrared patient position monitoring. These novel techniques for image co-registration, radiation dose calculations, and patient position monitoring will not alter or replace standard of care techniques.
Patient Quality of Life and Function (FACT-BP) Assessed 8 Weeks After Initial Treatment	15 Participants

SECONDARY outcome

Timeframe: 12 weeks post treatment

The patient's quality of life and function will be assessed using the Functional Assessment of Cancer Therapy (FACT-BP) survey 12 weeks post treatment. Min-'0'/'Not at all' and Maximum 4+ 'Very much.' Items scored per FACT\_BP Scoring guidelines version 4; Score Range 0-60; The higher the score, the better QOL function.

Outcome measures

Outcome measures
Measure	STAT RT Planning and Delivery Workflow n=28 Participants single arm STAT RT planning and delivery workflow: -Patients will receive simulation, planning, quality assurance, and their first treatment in a single day using the STAT RT workflow. * Patients will receive a total of 1-5 fractions of high dose palliative radiation therapy via TomoTherapy consisting of 5-10 Gray per fraction. * Data will be collected to evaluate the effectiveness of our novel image co-registration techniques, CT-detector-based exit dose calculations, and infrared patient position monitoring. These novel techniques for image co-registration, radiation dose calculations, and patient position monitoring will not alter or replace standard of care techniques.
Patient Quality of Life and Function (FACT-BP) Assessed 12 Weeks After Initial Treatment	15 Participants

SECONDARY outcome

Timeframe: 6 months post treatment

The patient's quality of life and function will be assessed using the Functional Assessment of Cancer Therapy (FACT-BP) survey 6 months post treatment. Min-'0'/'Not at all' and Maximum 4+ 'Very much.' Items scored per FACT\_BP Scoring guidelines version 4; Score Range 0-60; The higher the score, the better QOL function.

Outcome measures

Outcome measures
Measure	STAT RT Planning and Delivery Workflow n=28 Participants single arm STAT RT planning and delivery workflow: -Patients will receive simulation, planning, quality assurance, and their first treatment in a single day using the STAT RT workflow. * Patients will receive a total of 1-5 fractions of high dose palliative radiation therapy via TomoTherapy consisting of 5-10 Gray per fraction. * Data will be collected to evaluate the effectiveness of our novel image co-registration techniques, CT-detector-based exit dose calculations, and infrared patient position monitoring. These novel techniques for image co-registration, radiation dose calculations, and patient position monitoring will not alter or replace standard of care techniques.
Patient Quality of Life and Function (FACT-BP) Assessed 6 Months After Initial Treatment	13 Participants

SECONDARY outcome

Timeframe: 12 months post treatment

The patient's quality of life and function will be assessed using the Functional Assessment of Cancer Therapy (FACT-BP) survey 12 months post treatment. Min-'0'/'Not at all' and Maximum 4+ 'Very much.' Items scored per FACT\_BP Scoring guidelines version 4; Score Range 0-60; The higher the score, the better QOL function.

Outcome measures

Outcome measures
Measure	STAT RT Planning and Delivery Workflow n=28 Participants single arm STAT RT planning and delivery workflow: -Patients will receive simulation, planning, quality assurance, and their first treatment in a single day using the STAT RT workflow. * Patients will receive a total of 1-5 fractions of high dose palliative radiation therapy via TomoTherapy consisting of 5-10 Gray per fraction. * Data will be collected to evaluate the effectiveness of our novel image co-registration techniques, CT-detector-based exit dose calculations, and infrared patient position monitoring. These novel techniques for image co-registration, radiation dose calculations, and patient position monitoring will not alter or replace standard of care techniques.
Patient Quality of Life and Function (FACT-BP) Assessed 12 Months After Initial Treatment	10 Participants

SECONDARY outcome

Timeframe: 1 week post treatment

The patient's quality of life and function will be assessed using the Functional Assessment of Cancer Therapy (FACT-G) survey within 1 week post treatment. Min-'0'/'Not at All'; Max-'4'/'Very Much'; 28 questions total are broken into 4 categories scoring ranges 0-24 or 0-28 (depending on the category). Total score is ranged 0-108; Higher the score, the better quality of life (QOL).

Outcome measures

Outcome measures
Measure	STAT RT Planning and Delivery Workflow n=28 Participants single arm STAT RT planning and delivery workflow: -Patients will receive simulation, planning, quality assurance, and their first treatment in a single day using the STAT RT workflow. * Patients will receive a total of 1-5 fractions of high dose palliative radiation therapy via TomoTherapy consisting of 5-10 Gray per fraction. * Data will be collected to evaluate the effectiveness of our novel image co-registration techniques, CT-detector-based exit dose calculations, and infrared patient position monitoring. These novel techniques for image co-registration, radiation dose calculations, and patient position monitoring will not alter or replace standard of care techniques.
Patient Quality of Life and Function (FACT-G) Assessed 1 Week After Initial Treatment	19 Participants

SECONDARY outcome

Timeframe: 4 weeks post treatment

The patient's quality of life and function will be assessed using the Functional Assessment of Cancer Therapy (FACT-G) survey within 4 weeks post treatment. Min-'0'/'Not at All'; Max-'4'/'Very Much'; 28 questions total are broken into 4 categories scoring ranges 0-24 or 0-28 (depending on the category). Total score is ranged 0-108; Higher the score, the better quality of life (QOL).

Outcome measures

Outcome measures
Measure	STAT RT Planning and Delivery Workflow n=28 Participants single arm STAT RT planning and delivery workflow: -Patients will receive simulation, planning, quality assurance, and their first treatment in a single day using the STAT RT workflow. * Patients will receive a total of 1-5 fractions of high dose palliative radiation therapy via TomoTherapy consisting of 5-10 Gray per fraction. * Data will be collected to evaluate the effectiveness of our novel image co-registration techniques, CT-detector-based exit dose calculations, and infrared patient position monitoring. These novel techniques for image co-registration, radiation dose calculations, and patient position monitoring will not alter or replace standard of care techniques.
Patient Quality of Life and Function (FACT-G) Assessed 4 Weeks After Initial Treatment	21 Participants

SECONDARY outcome

Timeframe: 8 weeks post treatment

The patient's quality of life and function will be assessed using the Functional Assessment of Cancer Therapy (FACT-G) survey within 8 weeks post treatment. Min-'0'/'Not at All'; Max-'4'/'Very Much'; 28 questions total are broken into 4 categories scoring ranges 0-24 or 0-28 (depending on the category). Total score is ranged 0-108; Higher the score, the better quality of life (QOL).

Outcome measures

Outcome measures
Measure	STAT RT Planning and Delivery Workflow n=28 Participants single arm STAT RT planning and delivery workflow: -Patients will receive simulation, planning, quality assurance, and their first treatment in a single day using the STAT RT workflow. * Patients will receive a total of 1-5 fractions of high dose palliative radiation therapy via TomoTherapy consisting of 5-10 Gray per fraction. * Data will be collected to evaluate the effectiveness of our novel image co-registration techniques, CT-detector-based exit dose calculations, and infrared patient position monitoring. These novel techniques for image co-registration, radiation dose calculations, and patient position monitoring will not alter or replace standard of care techniques.
Patient Quality of Life and Function (FACT-G) Assessed 8 Weeks After Initial Treatment	15 Participants

SECONDARY outcome

Timeframe: 12 weeks post treatment.

The patient's quality of life and function will be assessed using the Functional Assessment of Cancer Therapy (FACT-G) survey within 12 weeks post treatment. Min-'0'/'Not at All'; Max-'4'/'Very Much'; 28 questions total are broken into 4 categories scoring ranges 0-24 or 0-28 (depending on the category). Total score is ranged 0-108; Higher the score, the better quality of life (QOL).

Outcome measures

Outcome measures
Measure	STAT RT Planning and Delivery Workflow n=28 Participants single arm STAT RT planning and delivery workflow: -Patients will receive simulation, planning, quality assurance, and their first treatment in a single day using the STAT RT workflow. * Patients will receive a total of 1-5 fractions of high dose palliative radiation therapy via TomoTherapy consisting of 5-10 Gray per fraction. * Data will be collected to evaluate the effectiveness of our novel image co-registration techniques, CT-detector-based exit dose calculations, and infrared patient position monitoring. These novel techniques for image co-registration, radiation dose calculations, and patient position monitoring will not alter or replace standard of care techniques.
Patient Quality of Life and Function (FACT-G) Assessed 12 Weeks After Initial Treatment	15 Participants

SECONDARY outcome

Timeframe: 6 months post treatment

The patient's quality of life and function will be assessed using the Functional Assessment of Cancer Therapy (FACT-G) survey within 6 months post treatment. Min-'0'/'Not at All'; Max-'4'/'Very Much'; 28 questions total are broken into 4 categories scoring ranges 0-24 or 0-28 (depending on the category). Total score is ranged 0-108; Higher the score, the better quality of life (QOL).

Outcome measures

Outcome measures
Measure	STAT RT Planning and Delivery Workflow n=28 Participants single arm STAT RT planning and delivery workflow: -Patients will receive simulation, planning, quality assurance, and their first treatment in a single day using the STAT RT workflow. * Patients will receive a total of 1-5 fractions of high dose palliative radiation therapy via TomoTherapy consisting of 5-10 Gray per fraction. * Data will be collected to evaluate the effectiveness of our novel image co-registration techniques, CT-detector-based exit dose calculations, and infrared patient position monitoring. These novel techniques for image co-registration, radiation dose calculations, and patient position monitoring will not alter or replace standard of care techniques.
Patient Quality of Life and Function (FACT-G) Assessed 6 Months After Initial Treatment	13 Participants

SECONDARY outcome

Timeframe: 12 months post treatment

The patient's quality of life and function will be assessed using the Functional Assessment of Cancer Therapy (FACT-G) survey within 12 months post treatment. Min-'0'/'Not at All'; Max-'4'/'Very Much'; 28 questions total are broken into 4 categories scoring ranges 0-24 or 0-28 (depending on the category). Total score is ranged 0-108; Higher the score, the better quality of life (QOL).

Outcome measures

Outcome measures
Measure	STAT RT Planning and Delivery Workflow n=28 Participants single arm STAT RT planning and delivery workflow: -Patients will receive simulation, planning, quality assurance, and their first treatment in a single day using the STAT RT workflow. * Patients will receive a total of 1-5 fractions of high dose palliative radiation therapy via TomoTherapy consisting of 5-10 Gray per fraction. * Data will be collected to evaluate the effectiveness of our novel image co-registration techniques, CT-detector-based exit dose calculations, and infrared patient position monitoring. These novel techniques for image co-registration, radiation dose calculations, and patient position monitoring will not alter or replace standard of care techniques.
Patient Quality of Life and Function (FACT-G) Assessed 12 Months After Initial Treatment	10 Participants

SECONDARY outcome

Timeframe: 1 week post treatment

Estimate patient satisfaction with the STAT RT workflow using Functional Assessment of Chronic Illness Therapy-Bone Treatment Convenience and Satisfaction Questionnaire (FACIT-TS-BTCSQ). Satisfaction will be assessed within 1 week post treatment. Min-'0'/'Not at All'; Max-'4'/'Very Much'; FACIT-TS-BTCSQ Baseline Scoring Guidelines (Version 4) includes sub of individual items multiplied by 13 to give score; The higher the score, the higher the quality of life (QOL).

Outcome measures

Outcome measures
Measure	STAT RT Planning and Delivery Workflow n=28 Participants single arm STAT RT planning and delivery workflow: -Patients will receive simulation, planning, quality assurance, and their first treatment in a single day using the STAT RT workflow. * Patients will receive a total of 1-5 fractions of high dose palliative radiation therapy via TomoTherapy consisting of 5-10 Gray per fraction. * Data will be collected to evaluate the effectiveness of our novel image co-registration techniques, CT-detector-based exit dose calculations, and infrared patient position monitoring. These novel techniques for image co-registration, radiation dose calculations, and patient position monitoring will not alter or replace standard of care techniques.
Patient Quality of Life and Function (FACIT-TS-BTCSQ) Assessed 1 Week After Initial Treatment	19 Participants

SECONDARY outcome

Timeframe: 4 weeks post treatment

Estimate patient satisfaction with the STAT RT workflow using Functional Assessment of Chronic Illness Therapy-Bone Treatment Convenience and Satisfaction Questionnaire (FACIT-TS-BTCSQ). Satisfaction will be assessed within 4 weeks post treatment. Min-'0'/'Not at All'; Max-'4'/'Very Much'; FACIT-TS-BTCSQ Baseline Scoring Guidelines (Version 4) includes sub of individual items multiplied by 13 to give score; The higher the score, the higher the quality of life (QOL).

Outcome measures

Outcome measures
Measure	STAT RT Planning and Delivery Workflow n=28 Participants single arm STAT RT planning and delivery workflow: -Patients will receive simulation, planning, quality assurance, and their first treatment in a single day using the STAT RT workflow. * Patients will receive a total of 1-5 fractions of high dose palliative radiation therapy via TomoTherapy consisting of 5-10 Gray per fraction. * Data will be collected to evaluate the effectiveness of our novel image co-registration techniques, CT-detector-based exit dose calculations, and infrared patient position monitoring. These novel techniques for image co-registration, radiation dose calculations, and patient position monitoring will not alter or replace standard of care techniques.
Patient Quality of Life and Function (FACIT-TS-BTCSQ) Assessed 4 Weeks After Initial Treatment	21 Participants

SECONDARY outcome

Timeframe: 8 weeks post treatment

Estimate patient satisfaction with the STAT RT workflow using Functional Assessment of Chronic Illness Therapy-Bone Treatment Convenience and Satisfaction Questionnaire (FACIT-TS-BTCSQ). Satisfaction will be assessed within 8 weeks post treatment. Min-'0'/'Not at All'; Max-'4'/'Very Much'; FACIT-TS-BTCSQ Baseline Scoring Guidelines (Version 4) includes sub of individual items multiplied by 13 to give score; The higher the score, the higher the quality of life (QOL).

Outcome measures

Outcome measures
Measure	STAT RT Planning and Delivery Workflow n=28 Participants single arm STAT RT planning and delivery workflow: -Patients will receive simulation, planning, quality assurance, and their first treatment in a single day using the STAT RT workflow. * Patients will receive a total of 1-5 fractions of high dose palliative radiation therapy via TomoTherapy consisting of 5-10 Gray per fraction. * Data will be collected to evaluate the effectiveness of our novel image co-registration techniques, CT-detector-based exit dose calculations, and infrared patient position monitoring. These novel techniques for image co-registration, radiation dose calculations, and patient position monitoring will not alter or replace standard of care techniques.
Patient Quality of Life and Function (FACIT-TS-BTCSQ) Assessed 8 Weeks After Initial Treatment	14 Participants

SECONDARY outcome

Timeframe: 12 weeks post treatment

Estimate patient satisfaction with the STAT RT workflow using Functional Assessment of Chronic Illness Therapy-Bone Treatment Convenience and Satisfaction Questionnaire (FACIT-TS-BTCSQ). Satisfaction will be assessed within 12 weeks post treatment. Min-'0'/'Not at All'; Max-'4'/'Very Much'; FACIT-TS-BTCSQ Baseline Scoring Guidelines (Version 4) includes sub of individual items multiplied by 13 to give score; The higher the score, the higher the quality of life (QOL).

Outcome measures

Outcome measures
Measure	STAT RT Planning and Delivery Workflow n=28 Participants single arm STAT RT planning and delivery workflow: -Patients will receive simulation, planning, quality assurance, and their first treatment in a single day using the STAT RT workflow. * Patients will receive a total of 1-5 fractions of high dose palliative radiation therapy via TomoTherapy consisting of 5-10 Gray per fraction. * Data will be collected to evaluate the effectiveness of our novel image co-registration techniques, CT-detector-based exit dose calculations, and infrared patient position monitoring. These novel techniques for image co-registration, radiation dose calculations, and patient position monitoring will not alter or replace standard of care techniques.
Patient Quality of Life and Function (FACIT-TS-BTCSQ) Assessed 12 Weeks After Initial Treatment	13 Participants

SECONDARY outcome

Timeframe: 6 months post treatment.

Estimate patient satisfaction with the STAT RT workflow using Functional Assessment of Chronic Illness Therapy-Bone Treatment Convenience and Satisfaction Questionnaire (FACIT-TS-BTCSQ). Satisfaction will be assessed within 6 months post treatment. Min-'0'/'Not at All'; Max-'4'/'Very Much'; FACIT-TS-BTCSQ Baseline Scoring Guidelines (Version 4) includes sub of individual items multiplied by 13 to give score; The higher the score, the higher the quality of life (QOL).

Outcome measures

Outcome measures
Measure	STAT RT Planning and Delivery Workflow n=28 Participants single arm STAT RT planning and delivery workflow: -Patients will receive simulation, planning, quality assurance, and their first treatment in a single day using the STAT RT workflow. * Patients will receive a total of 1-5 fractions of high dose palliative radiation therapy via TomoTherapy consisting of 5-10 Gray per fraction. * Data will be collected to evaluate the effectiveness of our novel image co-registration techniques, CT-detector-based exit dose calculations, and infrared patient position monitoring. These novel techniques for image co-registration, radiation dose calculations, and patient position monitoring will not alter or replace standard of care techniques.
Patient Quality of Life and Function (FACIT-TS-BTCSQ) Assessed 6 Months After Initial Treatment	13 Participants

SECONDARY outcome

Timeframe: 12 months post treatment

Estimate patient satisfaction with the STAT RT workflow using Functional Assessment of Chronic Illness Therapy-Bone Treatment Convenience and Satisfaction Questionnaire (FACIT-TS-BTCSQ). Satisfaction will be assessed within 12 months post treatment. Min-'0'/'Not at All'; Max-'4'/'Very Much'; FACIT-TS-BTCSQ Baseline Scoring Guidelines (Version 4) includes sub of individual items multiplied by 13 to give score; The higher the score, the higher the quality of life (QOL).

Outcome measures

Outcome measures
Measure	STAT RT Planning and Delivery Workflow n=28 Participants single arm STAT RT planning and delivery workflow: -Patients will receive simulation, planning, quality assurance, and their first treatment in a single day using the STAT RT workflow. * Patients will receive a total of 1-5 fractions of high dose palliative radiation therapy via TomoTherapy consisting of 5-10 Gray per fraction. * Data will be collected to evaluate the effectiveness of our novel image co-registration techniques, CT-detector-based exit dose calculations, and infrared patient position monitoring. These novel techniques for image co-registration, radiation dose calculations, and patient position monitoring will not alter or replace standard of care techniques.
Patient Quality of Life and Function (FACIT-TS-BTCSQ) Assessed 12 Months After Initial Treatment	9 Participants

Adverse Events

STAT RT Planning and Delivery Workflow

Serious events: 0 serious events

Other events: 12 other events

Deaths: 14 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	STAT RT Planning and Delivery Workflow n=28 participants at risk single arm STAT RT planning and delivery workflow: -Patients will receive simulation, planning, quality assurance, and their first treatment in a single day using the STAT RT workflow. * Patients will receive a total of 1-5 fractions of high dose palliative radiation therapy via TomoTherapy consisting of 5-10 Gray per fraction. * Data will be collected to evaluate the effectiveness of our novel image co-registration techniques, CT-detector-based exit dose calculations, and infrared patient position monitoring. These novel techniques for image co-registration, radiation dose calculations, and patient position monitoring will not alter or replace standard of care techniques.
General disorders Fatigue	14.3% 4/28 • Number of events 4 • 30 days following last study treatment. Per protocol, treatment may continue for 2 to 5 fractions depending of the clinical situation. Most subjects will receive treatments for less than 1 week, however, all treatments must be completed within 21 days. AEs will be collected for 30 days following the last treatment.
Gastrointestinal disorders Nausea	10.7% 3/28 • Number of events 3 • 30 days following last study treatment. Per protocol, treatment may continue for 2 to 5 fractions depending of the clinical situation. Most subjects will receive treatments for less than 1 week, however, all treatments must be completed within 21 days. AEs will be collected for 30 days following the last treatment.
Musculoskeletal and connective tissue disorders Bone Pain	14.3% 4/28 • Number of events 4 • 30 days following last study treatment. Per protocol, treatment may continue for 2 to 5 fractions depending of the clinical situation. Most subjects will receive treatments for less than 1 week, however, all treatments must be completed within 21 days. AEs will be collected for 30 days following the last treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	3.6% 1/28 • Number of events 1 • 30 days following last study treatment. Per protocol, treatment may continue for 2 to 5 fractions depending of the clinical situation. Most subjects will receive treatments for less than 1 week, however, all treatments must be completed within 21 days. AEs will be collected for 30 days following the last treatment.
Respiratory, thoracic and mediastinal disorders Cough	3.6% 1/28 • Number of events 1 • 30 days following last study treatment. Per protocol, treatment may continue for 2 to 5 fractions depending of the clinical situation. Most subjects will receive treatments for less than 1 week, however, all treatments must be completed within 21 days. AEs will be collected for 30 days following the last treatment.
Nervous system disorders Numbness	3.6% 1/28 • Number of events 1 • 30 days following last study treatment. Per protocol, treatment may continue for 2 to 5 fractions depending of the clinical situation. Most subjects will receive treatments for less than 1 week, however, all treatments must be completed within 21 days. AEs will be collected for 30 days following the last treatment.
Injury, poisoning and procedural complications Radiation dermatitis	3.6% 1/28 • Number of events 1 • 30 days following last study treatment. Per protocol, treatment may continue for 2 to 5 fractions depending of the clinical situation. Most subjects will receive treatments for less than 1 week, however, all treatments must be completed within 21 days. AEs will be collected for 30 days following the last treatment.
Injury, poisoning and procedural complications Rib fracture	3.6% 1/28 • Number of events 1 • 30 days following last study treatment. Per protocol, treatment may continue for 2 to 5 fractions depending of the clinical situation. Most subjects will receive treatments for less than 1 week, however, all treatments must be completed within 21 days. AEs will be collected for 30 days following the last treatment.

Additional Information

Dr. Paul Read

University of Virginia Department of Radiation Oncology

Phone: (434) 924-5191

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place