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

Malignant Neoplasms of Eye Brain and Other Parts of Central Nervous System Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT03028337
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Contact: Amol J. Ghia, MD
• Phone: 713-563-2300
• Email: CR_Study_Registration@mdanderson.org
• Status: Recruiting
• Phase: Phase 2
• Start date: January 18, 2017
• Completion date: May 30, 2028