NCT03028337

Single Versus Multifraction Salvage Spine Stereotactic Radiosurgery for Previously Irradiated Spinal Metastases

Single Versus Multifraction Salvage Spine Stereotactic Radiosurgery for Previously Irradiated Spinal Metastases: a Randomized Phase II Clinical Trial

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Malignant Neoplasms of Eye Brain and Other Parts of Central Nervous System

Interventions

Type	Name	Description
RADIATION	Spine Radiosurgery	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).
BEHAVIORAL	Questionnaires	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.

Timeline

• Start date: 2017-01-18
• Primary completion: 2028-05-30
• Completion: 2028-05-30
• First posted: 2017-01-23
• Last updated: 2026-03-05

Locations

1 site across 1 country: United States