Boston University Cancer Research Center
Boston, Massachusetts, 02118, United States
NCT Number: NCT00853528
RATIONALE: Stereotactic radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue. It may also help patients with spinal metastases live more comfortably.
PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiosurgery in treating patients with spinal metastases.
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Notify Me18 year and older
All sexes
Interventional
Phase 1
Boston, Massachusetts, 02118, United States
OBJECTIVES:
OUTLINE: Patients undergo placement of gold fiducial markers at the time of open surgical resection or percutaneous needle biopsy. Patients then undergo CyberKnife® hypofractionated stereotactic radiosurgery over 30-90 minutes daily for 2-3 days.
Patients undergo functional MRI and diffusion tensor imaging at baseline and then at 6 weeks and 6 months after completion of treatment. Patients also complete a pain questionnaire at baseline and then at 3, 6, 9, 12, 18, and 24 months after completion of treatment.
After completion of study treatment, patients are followed periodically for up to 2 years.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Exclusion criteria
PRIOR CONCURRENT THERAPY:
prior to radiosurgery, at radiosurgery completion, and then at subsequent follow-ups (3, 6, 9, 12, 18, and 24 months after treatment
prior to initiating CyberKnife radiosurgery, at 6 weeks after CyberKnife therapy, and at 6 months after CyberKnife therapy
prior to CyberKnife, at 6 weeks, and 3 months after CyberKnife?, every 3 months for the first year, and every 6 months thereafter
two to three consecutive daily sessions within one week for 3 cohorts- Cohort 1 = 21 Gy; Cohort 2 = 24 Gy; Cohort 3 = 27 Gy
two to three consecutive daily sessions within one week for 3 cohorts- for 3 cohorts- Cohort 1 = 16 Gy; Cohort 2 = 18 Gy; Cohort 3 = 20 Gy
Time frame: 6 weeks
Maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery
Time frame: 6 weeks
Maximum tolerated dose of CyberKnife® hypofractionated stereotactic radiosurgery
Time frame: baseline and then at 3, 6, 9, 12, 18, and 24 months after completion of treatment
Pain as measured by the Brief Pain Inventory and Roland scale
Time frame: baseline and then at 6 weeks and 6 months after completion of treatment
Spinal cord response as measured by functional MRI
Boston Medical Center
Other
Cyberknife Radiosurgery for Improving Palliation of Metastatic Tumors of the Spine
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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