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| Name | Class |
|---|---|
| Johns Hopkins University | OTHER |
| Massachusetts General Hospital | OTHER |
| Stanford University | OTHER |
The purpose of this study is to find out whether giving one higher dose of radiation is as good at treating the tumor in the patient's spine after surgery as giving three lower doses of radiation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single-fraction SRS (24 Gy) | Experimental | single-fraction (24Gy) SRS within eight weeks of having undergone spinal decompression surgery. |
|
| high-dose hypofractionated SRS (27 Gy in 3 fractions) | Experimental | hypofractionated (3 fractions of 9Gy, total dose of 27Gy) SRS within eight weeks of having undergone spinal decompression surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| single-fraction SRS | Radiation |
| ||
| high-dose hypofractionated SRS |
| Measure | Description | Time Frame |
|---|---|---|
| Local Tumor Control Using MRI or CT | will be radiographically determined according to routine standard of care post-surgical and post-treatment imaging (MRI or CT) of the spine. Local tumor control will be defined as the lack of local tumor progression at the irradiated site on follow-up imaging. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-related Toxicity Using CTCAE v4.0 | Adverse events will be assessed by the investigators according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 | 2 years |
| Quality of Life Between the Two Cohorts Determined Through Patient-reported Responses of the BPI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ilya Laufer | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Medical Center | Stanford | California | 94305-5408 | United States | ||
| John Hopkins Medical Center |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | High-dose Hypofractionated SRS (27 Gy in 3 Fractions) | hypofractionated (3 fractions of 9Gy, total dose of 27Gy) SRS within eight weeks of having undergone spinal decompression surgery. high-dose hypofractionated SRS Quality of Life Measures |
| FG001 | Single-fraction SRS (24 Gy) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 16, 2016 |
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| Radiation |
|
| Quality of Life Measures | Behavioral |
|
will be determined through patient-reported responses of the BPI. Pain severity at its worst (question #5) and the average of the pain interference (average of question #9) |
| 2 years |
| Baltimore |
| Maryland |
| 21287 |
| United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
single-fraction (24Gy) SRS within eight weeks of having undergone spinal decompression surgery. single-fraction SRS Quality of Life Measures |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High-dose Hypofractionated SRS (27 Gy in 3 Fractions) | hypofractionated (3 fractions of 9Gy, total dose of 27Gy) SRS within eight weeks of having undergone spinal decompression surgery. high-dose hypofractionated SRS Quality of Life Measures |
| BG001 | Single-fraction SRS (24 Gy) | single-fraction (24Gy) SRS within eight weeks of having undergone spinal decompression surgery. single-fraction SRS Quality of Life Measures |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Local Tumor Control Using MRI or CT | will be radiographically determined according to routine standard of care post-surgical and post-treatment imaging (MRI or CT) of the spine. Local tumor control will be defined as the lack of local tumor progression at the irradiated site on follow-up imaging. | Data were not collected | Posted | 2 years |
|
| ||||||||||||||||||||||
| Secondary | Treatment-related Toxicity Using CTCAE v4.0 | Adverse events will be assessed by the investigators according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 | Data were not collected | Posted | 2 years |
|
| ||||||||||||||||||||||
| Secondary | Quality of Life Between the Two Cohorts Determined Through Patient-reported Responses of the BPI | will be determined through patient-reported responses of the BPI. Pain severity at its worst (question #5) and the average of the pain interference (average of question #9) | Data were not collected | Posted | 2 years |
|
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High-dose Hypofractionated SRS (27 Gy in 3 Fractions) | hypofractionated (3 fractions of 9Gy, total dose of 27Gy) SRS within eight weeks of having undergone spinal decompression surgery. high-dose hypofractionated SRS Quality of Life Measures | 7 | 8 | 1 | 8 | 0 | 8 |
| EG001 | Single-fraction SRS (24 Gy) | single-fraction (24Gy) SRS within eight weeks of having undergone spinal decompression surgery. single-fraction SRS Quality of Life Measures | 5 | 8 | 0 | 8 | 0 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Esophagitis | Gastrointestinal disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ilya Laufer, MD | Memorial Sloan Kettering Cancer Center | 212-639-2368 | lauferi@mskcc.org |
| Jan 31, 2019 |
| Prot_SAP_000.pdf |
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|