Brief Summary
This pilot clinical trial studies adaptive staged stereotactic body radiation therapy (SBRT) in treating patients with spinal metastases that cannot be removed by surgery. SBRT is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Adaptive SBRT uses information gathered during treatment to inform, guide, and alter future radiation treatments. Staged SBRT uses multiple treatments separated by 2-3 weeks. Giving adaptive staged SBRT may work better in treating spinal metastases that cannot be removed by surgery.
Brief Title
Adaptive Staged Stereotactic Body Radiation Therapy in Treating Patients With Spinal Metastases That Cannot Be Removed by Surgery
Detailed Description
PRIMARY OBJECTIVES:
I. To assess the feasibility of single-fraction radiotherapy to provide a short-interval treatment response in patients with metastatic epidural spinal cord compression (MESCC), such that additional stereotactic radiotherapy to full therapeutic doses can be delivered while respecting spinal cord constraints, based on the following metrics: shortest distance between gross disease and the spinal cord before and after treatment; epidural tumor volume before and after treatment; and extent of epidural compression before and after treatment.
SECONDARY OBJECTIVES:
I. To evaluate pain control using the Numerical Rating Pain Scale (NRPS) before and after treatment.
II. To evaluate patient quality of life using the Functional Assessment of Cancer Therapy-General (FACT-G) before and after treatment.
III. To evaluate functional outcomes using ambulation score and standardized neurologic exams before and after treatment.
OUTLINE:
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.
After completion of study treatment, patients are followed up periodically.
I. To assess the feasibility of single-fraction radiotherapy to provide a short-interval treatment response in patients with metastatic epidural spinal cord compression (MESCC), such that additional stereotactic radiotherapy to full therapeutic doses can be delivered while respecting spinal cord constraints, based on the following metrics: shortest distance between gross disease and the spinal cord before and after treatment; epidural tumor volume before and after treatment; and extent of epidural compression before and after treatment.
SECONDARY OBJECTIVES:
I. To evaluate pain control using the Numerical Rating Pain Scale (NRPS) before and after treatment.
II. To evaluate patient quality of life using the Functional Assessment of Cancer Therapy-General (FACT-G) before and after treatment.
III. To evaluate functional outcomes using ambulation score and standardized neurologic exams before and after treatment.
OUTLINE:
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.
After completion of study treatment, patients are followed up periodically.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Melanoma
Metastatic Malignant Neoplasm in the Spine
Renal Cell Carcinoma
Soft Tissue Sarcoma
Spinal Cord Compression
Eligibility Criteria
Inclusion Criteria:
* Localized spine metastasis from the cervical (C)1 to lumbar (L)5 levels with documented epidural cord compression by a screening imaging study (magnetic resonance imaging \[MRI\] or computed tomography \[CT\] myelogram); site may have a maximal involvement of 2 contiguous vertebral bodies; patients with other visceral metastasis, and radioresistant tumors (including soft tissue sarcomas, melanomas, and renal cell carcinomas) are eligible
* History/physical examination by the treating physician within 24 hours prior to registration
* Neurological and functional examination within 24 hours prior to registration by the treating physician
* Negative serum pregnancy test
* MRI (contrast is not required but strongly recommended) or CT myelogram of the involved spine within 1 week prior to registration to determine the extent of the spine involvement
* Numerical rating pain scale within 1 week prior to registration; documentation of the patient's initial pain score is required; patients taking medication for pain at the time of registration are eligible
* Women of childbearing potential must:
* Have a negative serum or urine pregnancy test within 72 hours prior to the start of study therapy
* Agree to utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study therapy is completed
* Be advised of the importance of avoiding pregnancy during trial participation and the potential risks of an unintentional pregnancy
* All patients must sign study specific informed consent prior to study entry or within 1 week of first treatment, provided other criteria were met
* Patients considered for enrollment are strongly recommended to have been discussed at multidisciplinary tumor board with input from surgery, medical oncology and radiation oncology prior to enrollment
Exclusion Criteria:
* Histologies of myeloma or lymphoma
* Cord compression at 2 non-contiguous sites in the spine
* Favorable candidates for surgical decompression by prior documented criteria
* Spine instability as determined by Spinal Instability Neoplastic Score (SINS) score \> 12
* \> 50% loss of vertebral body height
* Bony retropulsion causing neurologic abnormality
* Prior radiation to the index spine
* Patients who cannot obtain a contrast-enhanced MRI or CT myelogram due to allergy, renal failure or other medical contraindication
* Localized spine metastasis from the cervical (C)1 to lumbar (L)5 levels with documented epidural cord compression by a screening imaging study (magnetic resonance imaging \[MRI\] or computed tomography \[CT\] myelogram); site may have a maximal involvement of 2 contiguous vertebral bodies; patients with other visceral metastasis, and radioresistant tumors (including soft tissue sarcomas, melanomas, and renal cell carcinomas) are eligible
* History/physical examination by the treating physician within 24 hours prior to registration
* Neurological and functional examination within 24 hours prior to registration by the treating physician
* Negative serum pregnancy test
* MRI (contrast is not required but strongly recommended) or CT myelogram of the involved spine within 1 week prior to registration to determine the extent of the spine involvement
* Numerical rating pain scale within 1 week prior to registration; documentation of the patient's initial pain score is required; patients taking medication for pain at the time of registration are eligible
* Women of childbearing potential must:
* Have a negative serum or urine pregnancy test within 72 hours prior to the start of study therapy
* Agree to utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study therapy is completed
* Be advised of the importance of avoiding pregnancy during trial participation and the potential risks of an unintentional pregnancy
* All patients must sign study specific informed consent prior to study entry or within 1 week of first treatment, provided other criteria were met
* Patients considered for enrollment are strongly recommended to have been discussed at multidisciplinary tumor board with input from surgery, medical oncology and radiation oncology prior to enrollment
Exclusion Criteria:
* Histologies of myeloma or lymphoma
* Cord compression at 2 non-contiguous sites in the spine
* Favorable candidates for surgical decompression by prior documented criteria
* Spine instability as determined by Spinal Instability Neoplastic Score (SINS) score \> 12
* \> 50% loss of vertebral body height
* Bony retropulsion causing neurologic abnormality
* Prior radiation to the index spine
* Patients who cannot obtain a contrast-enhanced MRI or CT myelogram due to allergy, renal failure or other medical contraindication
Inclusion Criteria
Inclusion Criteria:
* Localized spine metastasis from the cervical (C)1 to lumbar (L)5 levels with documented epidural cord compression by a screening imaging study (magnetic resonance imaging \[MRI\] or computed tomography \[CT\] myelogram); site may have a maximal involvement of 2 contiguous vertebral bodies; patients with other visceral metastasis, and radioresistant tumors (including soft tissue sarcomas, melanomas, and renal cell carcinomas) are eligible
* History/physical examination by the treating physician within 24 hours prior to registration
* Neurological and functional examination within 24 hours prior to registration by the treating physician
* Negative serum pregnancy test
* MRI (contrast is not required but strongly recommended) or CT myelogram of the involved spine within 1 week prior to registration to determine the extent of the spine involvement
* Numerical rating pain scale within 1 week prior to registration; documentation of the patient's initial pain score is required; patients taking medication for pain at the time of registration are eligible
* Women of childbearing potential must:
* Have a negative serum or urine pregnancy test within 72 hours prior to the start of study therapy
* Agree to utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study therapy is completed
* Be advised of the importance of avoiding pregnancy during trial participation and the potential risks of an unintentional pregnancy
* All patients must sign study specific informed consent prior to study entry or within 1 week of first treatment, provided other criteria were met
* Patients considered for enrollment are strongly recommended to have been discussed at multidisciplinary tumor board with input from surgery, medical oncology and radiation oncology prior to enrollment
* Localized spine metastasis from the cervical (C)1 to lumbar (L)5 levels with documented epidural cord compression by a screening imaging study (magnetic resonance imaging \[MRI\] or computed tomography \[CT\] myelogram); site may have a maximal involvement of 2 contiguous vertebral bodies; patients with other visceral metastasis, and radioresistant tumors (including soft tissue sarcomas, melanomas, and renal cell carcinomas) are eligible
* History/physical examination by the treating physician within 24 hours prior to registration
* Neurological and functional examination within 24 hours prior to registration by the treating physician
* Negative serum pregnancy test
* MRI (contrast is not required but strongly recommended) or CT myelogram of the involved spine within 1 week prior to registration to determine the extent of the spine involvement
* Numerical rating pain scale within 1 week prior to registration; documentation of the patient's initial pain score is required; patients taking medication for pain at the time of registration are eligible
* Women of childbearing potential must:
* Have a negative serum or urine pregnancy test within 72 hours prior to the start of study therapy
* Agree to utilize an adequate method of contraception throughout treatment and for at least 4 weeks after study therapy is completed
* Be advised of the importance of avoiding pregnancy during trial participation and the potential risks of an unintentional pregnancy
* All patients must sign study specific informed consent prior to study entry or within 1 week of first treatment, provided other criteria were met
* Patients considered for enrollment are strongly recommended to have been discussed at multidisciplinary tumor board with input from surgery, medical oncology and radiation oncology prior to enrollment
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02527304
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
2015-4957
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Adaptive Staged Stereotactic Body Radiation Therapy in Treating Patients With Spinal Metastases That Cannot Be Removed by Surgery
Primary Outcomes
Outcome Description
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.
Outcome Measure
Distance Between the Gross Disease and Spinal Cord (Cord-disease Distance, CDD) of at Least 3mm After Treatment.
Outcome Time Frame
Up to 10 weeks after first treatment
Outcome Description
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 Measure
Number of Participants Demonstrating Successful Radiographic Response of the Spinal Tumor
Outcome Time Frame
Up to 10 weeks after first treatment
Secondary Ids
Secondary Id
NCI-2015-01222
Secondary Id
007683
Secondary Id
2015-4957
Secondary Id
P30CA013330
Secondary Outcomes
Outcome Description
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 Time Frame
10 weeks after first treatment
Outcome Measure
Change in Ambulation (Mobility)
Outcome Description
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 Time Frame
Up to 10 weeks after first treatment
Outcome Measure
Change in Pain Control in Terms of Pain Scores as Measured by the Numeric Pain Rating Scale (NPRS) Estimation
Outcome Description
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 Time Frame
Up to 3 months following first treatment
Outcome Measure
Health Related Quality of Life Scores (FACT-G)
Outcome Description
Data will be reported in a descriptive manner to describe any incidence of greater than or equal to 3 treatment related toxicity
Outcome Time Frame
Up to 2 years
Outcome Measure
Incidence of Any Grade Greater Than or Equal to 3 Treatment-related Toxicity, Scored Using CTCAE, v. 4
Outcome Description
Data will be reported in a descriptive manner to describe any incidence of grade 2 or greater related radiation induced lung toxicity
Outcome Time Frame
Up to 2 years
Outcome Measure
Incidence of Grade Greater Than or Equal to 2 Radiation-induced Lung Toxicity (CTCAE), Version (v.) 4
Outcome Description
Data will be reported in a descriptive manner.
Outcome Time Frame
From study registration to death, censored at the date of data collection, assessed up to 2 years
Outcome Measure
Overall Survival
Outcome Description
Data will be reported in a descriptive manner.
Outcome Time Frame
From study registration to date of disease progression or death, censored at the date of data collection, assessed up to 2 years
Outcome Measure
Progression-free Survival
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Madhur Garg
Investigator Email
mgarg@montefiore.org
Investigator Phone