Mercy Medical Center, St. Louis
St Louis, Missouri, 63141, United States
NCT Number: NCT01347307
This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of spine metastases and benign spine tumors.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
St Louis, Missouri, 63141, United States
This study is a single site, non-randomized, prospective, phase IV trial. Patients are composed of 2 groups:Spine Metastases OR Benign Spine Tumors. Data collected will include patient demographics, pathology data, tumor stage, SBRT dose fractionation scheme, dose received by adjacent critical normal tissues, tumor recurrence data, and acute and late toxicities.
Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Eligibility Criteria:
Exclusion criteria
14-25 Gy / 1 fraction OR 21-27 Gy / 3 fractions (7-9 Gy per fraction) OR 25-30 Gy / 5 fractions (5-6 Gy per fraction)
Other names: Stereotactic Body Radiotherapy (SBRT)
12-16 Gy / 1 fraction OR 21-27 Gy / 3 fractions (7-9 Gy per fraction) OR 25-30 Gy / 5 fractions (5-6 Gy per fraction)
Other names: Stereotactic Body Radiotherapy (SBRT)
Time frame: 6 weeks post-SBRT (or at first post-treatment follow-up)
Evaluation of pain relief per patient report
Time frame: (1) At 1 year post-SBRT, (2) At patient's last follow-up or time of death
Local recurrence is defined as tumor recurrence or progression within the planning target volume.
Local control rate will be evaluated by imaging techniques and/or clinical symptoms (worsening or no improvement in pain or neurologic compromise). If follow-up imaging is available, a local recurrence will be defined as an increase of > 20% in tumor size.
Time frame: at patient's last follow-up (at least 3 months from treatment) or time of death
Toxicity will be assessed using CTCAE grading criteria at specified timepoints.
Mercy Research
Other
Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy for the Treatment of Spine Metastases and Primary Spine Tumors
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.
Published trials that share one or more normalized conditions with this study.
NCT02987153
Agnosia, Nervous System Diseases
Lake Success, New York, United States
View Trial DetailsNCT04248543
Spinal Metastases
Durham, North Carolina, United States
View Trial DetailsNCT06220071
Spinal Metastases
Berlin, Germany
View Trial DetailsNCT04497051
Spinal Metastases, Surgery
Taipei, Taiwan
View Trial Details