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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-00606 | Other Identifier | NCI-CTRP Clinical Trials Registry |
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The goal of this clinical research study is to learn whether delivering spine radiosurgery in a single large dose is better than delivering spine radiosurgery over 3 smaller doses.
Researchers also want to learn about the effects of a single dose on participant's symptoms, pain, and quality-of-life.
Study Groups:
Participant will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group.
Length of Study Participation:
Participant may continue taking part in the study as the doctor thinks it is in their best interest. Participant will no longer be able to take part if the disease gets worse, if intolerable side effects occur, or if they are unable to follow study directions.
Participation on the study will be over after participant's last follow-up visit.
Radiosurgery:
Participant will have spine radiosurgery in either 1 or 3 treatments as described above.
Participant will sign a separate consent for the surgery that explains the procedure and the risks.
Study Visits:
After surgery, at Months 3,6,9,12,18, and 24 and then every 6 months after that:
This is an investigational study. Delivering spine radiosurgery in a single large dose rather than over three smaller doses is considered investigational.
Up to 80 participants will be enrolled in this study. All will take part at MD Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spine Radiosurgery - 1 Dose | Experimental | Participants receive spine radiosurgery in a single large dose. |
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| Spine Radiosurgery - 3 Doses | Active Comparator | Participants receive spine radiosurgery over 3 smaller doses. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spine Radiosurgery | Radiation | Spine Radiosurgery - 1 Dose: For single fraction and multifraction arms, 0.01 cc of the cord allowed to receive 10 Gy and 14 Gy, respectively while 0.01 cc of the cauda equina allowed to receive 14 Gy and 18 Gy, respectively. Spine Radiosurgery - 3 Doses (3 days): The dose for the multifraction arm is 27 Gy in 3 fractions (9 Gy per fraction). |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Local Failure Relative to Multi-Fraction Radiosurgery in Patients with Previously Irradiated Spinal Metastases | Local failure determined based on the surveillance MRI scan by study musculoskeletal radiologist. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Relief Relative to Multi-Fraction Radiosurgery in Patients with Previously Irradiated Spinal Metastases | Pain relief assessed by items on the Brief Pain Inventory (BPI) that measure severity, location, and degree of relief due to therapy by use of narcotic and non-narcotic pain medications and steroids. Patients experiencing a decrease of 2 points in the worst pain score for 2 consecutive assessment visits considered to have "partial pain relief". Complete pain relief defined as an average pain score of 0 for 2 consecutive assessment visits. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amol J. Ghia, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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| Questionnaires | Behavioral | Participants complete 3 questionnaires about any pain they may be having, quality-of-life, and any other symptoms. It should take about 10 minutes to complete these questionnaires. Questionnaires completed at Baseline and at Months 3,6,9,12,18, and 24 and then every 6 months after that during follow up. |
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| 2 years |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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