Trial for Salvage Re-Irradiation of Metastatic Spine Lesions Using Single-Fraction Stereotactic R… (NCT02278744) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Trial for Salvage Re-Irradiation of Metastatic Spine Lesions Using Single-Fraction Stereotactic Radiosurgery
United States9 participantsStarted 2014-10-27
Plain-language summary
This is a phase I clinical trial investigating the use of single fraction re-irradiation following local progression of spine and cauda equina (L2 to sacrum) lesions that have previously received radiation therapy. Patients will be treated with single-fraction radiation therapy at 3 dose levels using image-guided stereotactic radiosurgery techniques.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have histologic or cytologic proof of a non-hematologic malignancy confirmed by MSKCC pathologic review
* Patients must have radiographic evidence of malignancy in the spine or cauda equina region (L2 to sacrum) which is suitable for radiation therapy
* Patients must have received prior external beam radiation therapy to the region proposed for SRS re-irradiation at least 6 months prior to planned re-irradiation
* For patients who were previously treated at an outside institution, adequate records must be available to determine the true dose the cord/cauda received during prior RT. Sufficiency of the treatment records will be assessed and signed-off by the Medical Physics investigator.
* Patients must have demonstrated progression of disease on MRI or CT assessment of the spinal cord/cauda within the previous radiation field
o progression may consist of an increase in maximal dimension of the tumor by ≥20%, compromise of the spinal cord/cauda equina and/or exiting spinal nerves (assessed clinically or radiographically), or both.
* Target lesion size for re-irradiation must be ≤ 2 vertebral bodies
* KPS ≥ 60%
* Age ≥ 18 years old
Exclusion Criteria:
* Patients with a life expectancy of \< 6 months as predicted by the Adult Comorbidity Index (ACE-27, see Appendix 1).
* Patients with intradural or intramedullary lesions, or lesions with \< 2mm distance from tumor to spinal cord
* Patients with circumferential epidural disease
* Systemic …
What they're measuring
1
toxicities as measured by the National Cancer Institute (NCI) Common Toxicity Criteria