Trial Outcomes & Findings for Adaptive Staged Stereotactic Body Radiation Therapy in Treating Patients With Spinal Metastases That Cannot Be Removed by Surgery (NCT NCT02527304)

Last Updated: 2024-03-06

Results Overview

Cord-disease distance of at least 3mm in shortest axial distance after treatment. Data was summarized using standard descriptive statistics; formal hypothesis testing was not performed. Confidence intervals for the true proportion were computed using Clopper-Pearson exact confidence interval were not conducted. Since this was a feasibility, study no power calculation was done.

Recruitment status

COMPLETED

Study phase

Target enrollment

24 participants

Primary outcome timeframe

Up to 10 weeks after first treatment

Results posted on

2024-03-06

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment (Adaptive Staged SBRT) Patients undergo adaptive staged SBRT. Within 14-21 days, patients may undergo a second treatment of adaptive staged SBRT at the discretion of the treating physician based on clinical parameters, diagnostic interval imaging, and achievement of spinal cord dose constraints. Image-Guided Adaptive Radiation Therapy: Undergo adaptive staged SBRT Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Stereotactic Body Radiation Therapy: Undergo adaptive staged SBRT
Overall Study STARTED	24
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Adaptive Staged Stereotactic Body Radiation Therapy in Treating Patients With Spinal Metastases That Cannot Be Removed by Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Adaptive Staged SBRT) n=24 Participants Patients undergo adaptive staged SBRT. Within 14-21 days, patients may undergo a second treatment of adaptive staged SBRT at the discretion of the treating physician based on clinical parameters, diagnostic interval imaging, and achievement of spinal cord dose constraints. Image-Guided Adaptive Radiation Therapy: Undergo adaptive staged SBRT Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Stereotactic Body Radiation Therapy: Undergo adaptive staged SBRT
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=93 Participants
Age, Categorical >=65 years	14 Participants n=93 Participants
Age, Continuous	66.5 years n=93 Participants
Sex: Female, Male Female	8 Participants n=93 Participants
Sex: Female, Male Male	16 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	12 Participants n=93 Participants
Race (NIH/OMB) White	4 Participants n=93 Participants
Race (NIH/OMB) More than one race	5 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=93 Participants
Region of Enrollment United States	24 Participants n=93 Participants
Numeric Pain Rating Scale	4.31 units on a scale STANDARD_DEVIATION 3 • n=93 Participants

PRIMARY outcome

Timeframe: Up to 10 weeks after first treatment

Population: Data was not collected and analyzed for 9 participants due to no post-treatment imaging being obtained. Imaging was unable to be conducted for these participants due to either a decline in subjects' clinical status or death. Confidence intervals were not determined given data limitations and had no impact due to feasibility design of study.

Outcome measures

Outcome measures
Measure	Treatment (Adaptive Staged SBRT) n=15 Participants Patients undergo adaptive staged SBRT. Within 14-21 days, patients may undergo a second treatment of adaptive staged SBRT at the discretion of the treating physician based on clinical parameters, diagnostic interval imaging, and achievement of spinal cord dose constraints. Image-Guided Adaptive Radiation Therapy: Undergo adaptive staged SBRT Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Stereotactic Body Radiation Therapy: Undergo adaptive staged SBRT
Distance Between the Gross Disease and Spinal Cord (Cord-disease Distance, CDD) of at Least 3mm After Treatment. met primary endpoint of CDD >3 mm	1 Participants
Distance Between the Gross Disease and Spinal Cord (Cord-disease Distance, CDD) of at Least 3mm After Treatment. did not meet primary endpoint of CDD >3 mm	14 Participants

PRIMARY outcome

Timeframe: Up to 10 weeks after first treatment

Population: Data was not collected and analyzed for 10 participants due to no post-treatment MRI or CT myelograms being obtained. Imaging was unable to be conducted for these 10 participants due to either a decline in subjects' clinical status or death. Confidence intervals were not determined given data limitations and had no impact due to feasibility design of study.

Successful radiographic response of the spinal tumor was determined by achieving of a 10% reduction in epidural volume or thecal sac compression (i.e., \~10% absolute increase in thecal sac patency (TSP)) following treatment, on either of their MRI imaging or CT myelogram scans. Data was summarized using standard descriptive statistics; formal hypothesis testing was not performed. Confidence intervals for the true proportion using Clopper-Pearson exact confidence interval were not conducted. Since this is a feasibility study no power calculation was done.

Outcome measures

Outcome measures
Measure	Treatment (Adaptive Staged SBRT) n=14 Participants Patients undergo adaptive staged SBRT. Within 14-21 days, patients may undergo a second treatment of adaptive staged SBRT at the discretion of the treating physician based on clinical parameters, diagnostic interval imaging, and achievement of spinal cord dose constraints. Image-Guided Adaptive Radiation Therapy: Undergo adaptive staged SBRT Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Stereotactic Body Radiation Therapy: Undergo adaptive staged SBRT
Number of Participants Demonstrating Successful Radiographic Response of the Spinal Tumor Participants with significant TSP difference	8 Participants
Number of Participants Demonstrating Successful Radiographic Response of the Spinal Tumor Participants without significant TSP difference	6 Participants

SECONDARY outcome

Timeframe: 10 weeks after first treatment

Ambulation was assessed as a functional outcome by the treating physician. Scoring was adapted from the ICORG Phase III trial, ASTRO 2014. Mobility scores were assigned as follows: 1 = ambulatory without aid; 2 = ambulatory with aid; 3 = not ambulatory; and 4 = paraplegia. Basic descriptive statistics were used to assess changes in ambulation from baseline.

Outcome measures

Outcome measures
Measure	Treatment (Adaptive Staged SBRT) n=24 Participants Patients undergo adaptive staged SBRT. Within 14-21 days, patients may undergo a second treatment of adaptive staged SBRT at the discretion of the treating physician based on clinical parameters, diagnostic interval imaging, and achievement of spinal cord dose constraints. Image-Guided Adaptive Radiation Therapy: Undergo adaptive staged SBRT Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Stereotactic Body Radiation Therapy: Undergo adaptive staged SBRT
Change in Ambulation (Mobility)	.3 Change in ambulation measure score Standard Deviation 3

SECONDARY outcome

Timeframe: Up to 10 weeks after first treatment

Population: Data was not collected and analyzed for all patient due to diminishing clinical status or death.

Participants were asked to provide a numeric value using the NPRS to describe their pain intensity. The NPRS is a unidimensional assessment tool which measures pain on an 11-point (0-10) numeric scale where "0" represents no pain and "10" represents extreme pain. Higher scores are indicative of worsening pain intensity.

Outcome measures

Outcome measures
Measure	Treatment (Adaptive Staged SBRT) n=22 Participants Patients undergo adaptive staged SBRT. Within 14-21 days, patients may undergo a second treatment of adaptive staged SBRT at the discretion of the treating physician based on clinical parameters, diagnostic interval imaging, and achievement of spinal cord dose constraints. Image-Guided Adaptive Radiation Therapy: Undergo adaptive staged SBRT Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Stereotactic Body Radiation Therapy: Undergo adaptive staged SBRT
Change in Pain Control in Terms of Pain Scores as Measured by the Numeric Pain Rating Scale (NPRS) Estimation pretreatment best	4.3 score on a scale Standard Deviation 3
Change in Pain Control in Terms of Pain Scores as Measured by the Numeric Pain Rating Scale (NPRS) Estimation pretreatment worst	7.18 score on a scale Standard Deviation 2.8
Change in Pain Control in Terms of Pain Scores as Measured by the Numeric Pain Rating Scale (NPRS) Estimation weeks 2-4 best	3.46 score on a scale Standard Deviation 2.6
Change in Pain Control in Terms of Pain Scores as Measured by the Numeric Pain Rating Scale (NPRS) Estimation weeks 2-4 worst	5.85 score on a scale Standard Deviation 3.7
Change in Pain Control in Terms of Pain Scores as Measured by the Numeric Pain Rating Scale (NPRS) Estimation weeks 8-10 best	2.85 score on a scale Standard Deviation 3.6
Change in Pain Control in Terms of Pain Scores as Measured by the Numeric Pain Rating Scale (NPRS) Estimation weeks 8-10 worst	6 score on a scale Standard Deviation 3.5

SECONDARY outcome

Timeframe: Up to 3 months following first treatment

Population: Data was not collected and analyzed for 15 participants due to either a decline in subjects' clinical status or death.

Health-related Quality of Life was measured using Functional Assessment of Cancer Therapy - General (FACT-G) a 27-item questionnaire designed to measure four domains of Quality of Life in cancer patients assessed over the previous 7-day period: physical well-being (7 questions), social/family well-being (7 questions), emotional being (6 questions), and functional well-being (7 questions). Participant responses are assessed using a 5 point Likert-type scale ranging from 0 (Not at all) to 4 (Very much). A FACT-G total score is computed as the sum of the four subscale scores, provided the overall item response is at least 80% (i.e. at least 22 of the 27 items answered) and has a possible range of 0-108 points. Negatively worded items are reverse scored prior to summing so that higher subscale and total scores indicate a better overall health state corresponding Quality of Life.

Outcome measures

Outcome measures
Measure	Treatment (Adaptive Staged SBRT) n=9 Participants Patients undergo adaptive staged SBRT. Within 14-21 days, patients may undergo a second treatment of adaptive staged SBRT at the discretion of the treating physician based on clinical parameters, diagnostic interval imaging, and achievement of spinal cord dose constraints. Image-Guided Adaptive Radiation Therapy: Undergo adaptive staged SBRT Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Stereotactic Body Radiation Therapy: Undergo adaptive staged SBRT
Health Related Quality of Life Scores (FACT-G)	5 score on a scale Standard Deviation 3

SECONDARY outcome

Timeframe: Up to 2 years

Data will be reported in a descriptive manner to describe any incidence of greater than or equal to 3 treatment related toxicity

Outcome measures

Outcome measures
Measure	Treatment (Adaptive Staged SBRT) n=24 Participants Patients undergo adaptive staged SBRT. Within 14-21 days, patients may undergo a second treatment of adaptive staged SBRT at the discretion of the treating physician based on clinical parameters, diagnostic interval imaging, and achievement of spinal cord dose constraints. Image-Guided Adaptive Radiation Therapy: Undergo adaptive staged SBRT Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Stereotactic Body Radiation Therapy: Undergo adaptive staged SBRT
Incidence of Any Grade Greater Than or Equal to 3 Treatment-related Toxicity, Scored Using CTCAE, v. 4	0 Participants

SECONDARY outcome

Timeframe: Up to 2 years

Data will be reported in a descriptive manner to describe any incidence of grade 2 or greater related radiation induced lung toxicity

Outcome measures

Outcome measures
Measure	Treatment (Adaptive Staged SBRT) n=24 Participants Patients undergo adaptive staged SBRT. Within 14-21 days, patients may undergo a second treatment of adaptive staged SBRT at the discretion of the treating physician based on clinical parameters, diagnostic interval imaging, and achievement of spinal cord dose constraints. Image-Guided Adaptive Radiation Therapy: Undergo adaptive staged SBRT Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Stereotactic Body Radiation Therapy: Undergo adaptive staged SBRT
Incidence of Grade Greater Than or Equal to 2 Radiation-induced Lung Toxicity (CTCAE), Version (v.) 4	0 Participants

SECONDARY outcome

Timeframe: From study registration to death, censored at the date of data collection, assessed up to 2 years

Population: patients

Data will be reported in a descriptive manner.

Outcome measures

Outcome measures
Measure	Treatment (Adaptive Staged SBRT) n=13 Participants Patients undergo adaptive staged SBRT. Within 14-21 days, patients may undergo a second treatment of adaptive staged SBRT at the discretion of the treating physician based on clinical parameters, diagnostic interval imaging, and achievement of spinal cord dose constraints. Image-Guided Adaptive Radiation Therapy: Undergo adaptive staged SBRT Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Stereotactic Body Radiation Therapy: Undergo adaptive staged SBRT
Overall Survival	13 Participants

SECONDARY outcome

Timeframe: From study registration to date of disease progression or death, censored at the date of data collection, assessed up to 2 years

Data will be reported in a descriptive manner.

Outcome measures

Outcome measures
Measure	Treatment (Adaptive Staged SBRT) n=13 Participants Patients undergo adaptive staged SBRT. Within 14-21 days, patients may undergo a second treatment of adaptive staged SBRT at the discretion of the treating physician based on clinical parameters, diagnostic interval imaging, and achievement of spinal cord dose constraints. Image-Guided Adaptive Radiation Therapy: Undergo adaptive staged SBRT Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Stereotactic Body Radiation Therapy: Undergo adaptive staged SBRT
Progression-free Survival	12 Participants

Adverse Events

Treatment (Adaptive Staged SBRT)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment (Adaptive Staged SBRT) n=24 participants at risk Patients undergo adaptive staged SBRT. Within 14-21 days, patients may undergo a second treatment of adaptive staged SBRT at the discretion of the treating physician based on clinical parameters, diagnostic interval imaging, and achievement of spinal cord dose constraints. Image-Guided Adaptive Radiation Therapy: Undergo adaptive staged SBRT Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies Stereotactic Body Radiation Therapy: Undergo adaptive staged SBRT
General disorders Fatigue	20.8% 5/24 • Up to time of final imaging visit, approximately 8-10 weeks following initial treatment, unless otherwise clinically indicated
Renal and urinary disorders Urinary Frequency (Increased)	4.2% 1/24 • Up to time of final imaging visit, approximately 8-10 weeks following initial treatment, unless otherwise clinically indicated
Gastrointestinal disorders Esophagitis	4.2% 1/24 • Up to time of final imaging visit, approximately 8-10 weeks following initial treatment, unless otherwise clinically indicated
Gastrointestinal disorders Dysphagia	4.2% 1/24 • Up to time of final imaging visit, approximately 8-10 weeks following initial treatment, unless otherwise clinically indicated
Gastrointestinal disorders Diarrhea	4.2% 1/24 • Up to time of final imaging visit, approximately 8-10 weeks following initial treatment, unless otherwise clinically indicated
Metabolism and nutrition disorders Anorexia	4.2% 1/24 • Up to time of final imaging visit, approximately 8-10 weeks following initial treatment, unless otherwise clinically indicated
Gastrointestinal disorders Mucositis oral	4.2% 1/24 • Up to time of final imaging visit, approximately 8-10 weeks following initial treatment, unless otherwise clinically indicated
Eye disorders Conjuctivitis	4.2% 1/24 • Up to time of final imaging visit, approximately 8-10 weeks following initial treatment, unless otherwise clinically indicated
Infections and infestations Paronychia	4.2% 1/24 • Up to time of final imaging visit, approximately 8-10 weeks following initial treatment, unless otherwise clinically indicated
Gastrointestinal disorders Nausea	4.2% 1/24 • Up to time of final imaging visit, approximately 8-10 weeks following initial treatment, unless otherwise clinically indicated
Investigations Weight Loss	4.2% 1/24 • Up to time of final imaging visit, approximately 8-10 weeks following initial treatment, unless otherwise clinically indicated
Skin and subcutaneous tissue disorders Rash (nonspecific)	4.2% 1/24 • Up to time of final imaging visit, approximately 8-10 weeks following initial treatment, unless otherwise clinically indicated
Musculoskeletal and connective tissue disorders Back Pain	4.2% 1/24 • Up to time of final imaging visit, approximately 8-10 weeks following initial treatment, unless otherwise clinically indicated
Infections and infestations Urinary Tract Infection	4.2% 1/24 • Up to time of final imaging visit, approximately 8-10 weeks following initial treatment, unless otherwise clinically indicated
Blood and lymphatic system disorders Anemia	4.2% 1/24 • Up to time of final imaging visit, approximately 8-10 weeks following initial treatment, unless otherwise clinically indicated

Additional Information

Dr. Madhur Garg, Clinical Director, Department of Radiation Oncology

Montefiore Medical Center

Phone: 718-920-4361

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place