N/A
Completed N=21
Stereotactic Body Radiation Therapy (SBRT) for Tumors Near the Spinal Cord
Spinal Tumors
Source: ClinicalTrials.gov NCT00631670 ↗
Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Jan 2012
Primary outcomePrimary: Toxicity — 14; 0; 0; 0 participants
Summary
The purpose of this research study is to determine if Stereotactic Body Radiation Therapy (SBRT) is a good way to treat tumors near the spinal cord. Patients will either receive a single treatment or 25 days of treatment given once-a-day, Monday through Friday for about 5 continuous weeks. Our protocol uses life expectancy, patient preference, and tumor size to determine whether SBRT is delivered with 1 or 25 treatments. The single treatment dose is 15 Gy. The 25 treatment group is 70 Gy at 2.8 Gy/treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Toxicity |
14; 0; 0; 0 | — |
| SECONDARY Local Control |
24 | — |
| SECONDARY Neurologic Function |
0; 6; 0 | — |
| SECONDARY Pain Relief |
6 | — |
| SECONDARY Overall One Year Survival |
5 | — |
Eligibility Criteria
Inclusion Criteria
- Informed consent to participate in this protocol
- Patient of all ages are eligible
- All tumor types are eligible
- Patients with prior spine radiotherapy and/or surgery to the involved area are eligible
- The tumor target must be visible on MRI or CT scan
- Stereotactic Body Radiation Therapy (SBRT) on this protocol may produce a better outcome than conventional radiotherapy
Exclusion Criteria
- Patients who are likely to have a satisfactory outcome with surgical resection, embolization, or radiofrequency ablation without the addition of radiotherapy
- Tumor size, shape, or location is such that it is not reasonable to think the patient may benefit from SBRT as given in this protocol
- The full extent of the tumor cannot be visualized on MRI or CT scan
- Delaying radiotherapy for the time that it takes to start SBRT may compromise outcome compared to starting conventional radiotherapy immediately
- The patient cannot be positioned reproducibly due to pain or other factors
Data sourced from ClinicalTrials.gov (NCT00631670). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.