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. * If participant is in Group 1, they will receive spine radiosurgery in a single large dose. * If participant is in Group 2, they will receive spine radiosurgery over 3 smaller doses, which is standard. 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: * Participant will have a physical exam, including a neurological exam (tests to check the functioning of their nerves, including tests of their strength and sensation. * Participant will complete the same questionnaires they completed at the beginning of the study. * Participant will have an MRI. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
80
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).
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.
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGTime 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.
Time frame: 12 months
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.
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.