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

Primary Purpose

Melanoma, Metastatic Malignant Neoplasm in the Spine, Renal Cell Carcinoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Image-Guided Adaptive Radiation Therapy
Quality-of-Life Assessment
Questionnaire Administration
Stereotactic Body Radiation Therapy
Sponsored by
Albert Einstein College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Albert Einstein College of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (adaptive staged SBRT)

Arm Description

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.

Outcomes

Primary Outcome Measures

Radiographic response of the spinal tumor, as measured by a reduction in the epidural tumor volume greater than or equal to 10% after treatment on imaging scans (MRI or CT myelogram)
Data will be summarized using standard descriptive statistics; formal hypothesis testing will not be performed. Confidence intervals for the true proportion will be computed using Clopper-Pearson exact confidence interval. The width shows that the response rate will not be lower than 20%. Since this is a feasibility, study no power calculation is done.
Radiographic response of the spinal tumor, as measured by a reduction in thecal sac compression by greater than or equal to 10% after treatment on imaging scans (MRI or CT myelogram)
Data will be summarized using standard descriptive statistics; formal hypothesis testing will not be performed. Confidence intervals for the true proportion will be computed using Clopper-Pearson exact confidence interval. The width shows that the response rate will not be lower than 20%. Since this is a feasibility, study no power calculation is done.
Radiographic response of the spinal tumor, as measured by distance between the gross disease and spinal cord greater than or equal to 3 mm after treatment on imaging scans (MRI or CT myelogram)
Data will be summarized using standard descriptive statistics; formal hypothesis testing will not be performed. Confidence intervals for the true proportion will be computed using Clopper-Pearson exact confidence interval. The width shows that the response rate will not be lower than 20%. Since this is a feasibility, study no power calculation is done.

Secondary Outcome Measures

Change in ambulation based on ambulation score and standardized neurologic exam
Data will be reported in a descriptive manner.
Change in pain control in terms of pain scores as measured by the NRPS estimation
Data will be reported in a descriptive manner.
Change in quality of life scores from FACT-G
Data will be reported in a descriptive manner.
Incidence of any grade greater than or equal to 3 treatment-related toxicity, scored using CTCAE, v. 4
Data will be reported in a descriptive manner.
Incidence of grade greater than or equal to 2 radiation-induced lung toxicity, scored using Common Toxicity Criteria for Adverse Events (CTCAE), version (v.) 4
Data will be reported in a descriptive manner.
Overall survival
Data will be reported in a descriptive manner.
Progression-free survival
Data will be reported in a descriptive manner.

Full Information

First Posted
August 17, 2015
Last Updated
December 30, 2019
Sponsor
Albert Einstein College of Medicine
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02527304
Brief Title
Adaptive Staged Stereotactic Body Radiation Therapy in Treating Patients With Spinal Metastases That Cannot Be Removed by Surgery
Official Title
Adaptive Staged Stereotactic Body Radiation Therapy in Treating Patients With Spinal Metastases That Cannot Be Removed by Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albert Einstein College of Medicine
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma, Metastatic Malignant Neoplasm in the Spine, Renal Cell Carcinoma, Soft Tissue Sarcoma, Spinal Cord Compression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (adaptive staged SBRT)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Image-Guided Adaptive Radiation Therapy
Other Intervention Name(s)
IGART
Intervention Description
Undergo adaptive staged SBRT
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiation Therapy
Other Intervention Name(s)
SBRT
Intervention Description
Undergo adaptive staged SBRT
Primary Outcome Measure Information:
Title
Radiographic response of the spinal tumor, as measured by a reduction in the epidural tumor volume greater than or equal to 10% after treatment on imaging scans (MRI or CT myelogram)
Description
Data will be summarized using standard descriptive statistics; formal hypothesis testing will not be performed. Confidence intervals for the true proportion will be computed using Clopper-Pearson exact confidence interval. The width shows that the response rate will not be lower than 20%. Since this is a feasibility, study no power calculation is done.
Time Frame
Up to 10 weeks after first treatment
Title
Radiographic response of the spinal tumor, as measured by a reduction in thecal sac compression by greater than or equal to 10% after treatment on imaging scans (MRI or CT myelogram)
Description
Data will be summarized using standard descriptive statistics; formal hypothesis testing will not be performed. Confidence intervals for the true proportion will be computed using Clopper-Pearson exact confidence interval. The width shows that the response rate will not be lower than 20%. Since this is a feasibility, study no power calculation is done.
Time Frame
Up to 10 weeks after first treatment
Title
Radiographic response of the spinal tumor, as measured by distance between the gross disease and spinal cord greater than or equal to 3 mm after treatment on imaging scans (MRI or CT myelogram)
Description
Data will be summarized using standard descriptive statistics; formal hypothesis testing will not be performed. Confidence intervals for the true proportion will be computed using Clopper-Pearson exact confidence interval. The width shows that the response rate will not be lower than 20%. Since this is a feasibility, study no power calculation is done.
Time Frame
Up to 10 weeks after first treatment
Secondary Outcome Measure Information:
Title
Change in ambulation based on ambulation score and standardized neurologic exam
Description
Data will be reported in a descriptive manner.
Time Frame
Baseline to week 10 after first treatment
Title
Change in pain control in terms of pain scores as measured by the NRPS estimation
Description
Data will be reported in a descriptive manner.
Time Frame
Baseline to week 10 after first treatment
Title
Change in quality of life scores from FACT-G
Description
Data will be reported in a descriptive manner.
Time Frame
Baseline to up to 3 months
Title
Incidence of any grade greater than or equal to 3 treatment-related toxicity, scored using CTCAE, v. 4
Description
Data will be reported in a descriptive manner.
Time Frame
Up to 2 years
Title
Incidence of grade greater than or equal to 2 radiation-induced lung toxicity, scored using Common Toxicity Criteria for Adverse Events (CTCAE), version (v.) 4
Description
Data will be reported in a descriptive manner.
Time Frame
Up to 2 years
Title
Overall survival
Description
Data will be reported in a descriptive manner.
Time Frame
From study registration to death, censored at the date of data collection, assessed up to 2 years
Title
Progression-free survival
Description
Data will be reported in a descriptive manner.
Time Frame
From study registration to date of disease progression or death, censored at the date of data collection, assessed up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Madhur Garg
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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