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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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 Summary:

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
    Sponsor: M.D. Anderson Cancer Center

    Current Primary Outcome: Time to Local Failure Relative to Multi-Fraction Radiosurgery in Patients with Previously Irradiated Spinal Metastases [ Time Frame: 12 months ]

    Local failure determined based on the surveillance MRI scan by study musculoskeletal radiologist.


    Original Primary Outcome: Same as current

    Current Secondary Outcome: Pain Relief Relative to Multi-Fraction Radiosurgery in Patients with Previously Irradiated Spinal Metastases [ Time Frame: 2 years ]

    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.


    Original Secondary Outcome: Same as current

    Information By: M.D. Anderson Cancer Center

    Dates:
    Date Received: January 19, 2017
    Date Started: January 18, 2017
    Date Completion: January 18, 2022
    Last Updated: April 20, 2017
    Last Verified: April 2017