Comparing SingLe- Vs Multi-Fraction Spine STereotActic Radiosurgery in Spinal Metastases
The goal of this study is to determine whether fractionated Stereotactic radiosurgery (SRS) for spine metastases is associated with improved local tumor control compared to single-fraction SRS. Patients will be randomized to treatment with spine SRS using either 22 Gy in 1 fraction or 28 Gy in 2 fractions.
| Condition(s) | Spinal Metastases |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | The goal of this study is to determine whether fractionated Stereotactic radiosurgery (SRS) for spine metastases is associated with improved local tumor control compared to single-fraction SRS. Patients will be randomized to treatment with spine SRS using either 22 Gy in 1 fraction or 28 Gy in 2 fractions. |
| Who can participate | Inclusion Criteria: * Histologically, cytologically, or radiographically confirmed diagnosis of metastatic cancer Age ≥ 18 years * Patients who have cervical, thoracic, or lumbar spine metastasis that need treatment. * Patients will have 1 to 3 separate spinal sites that require treatment. * Each spinal site to be treated on trial will span 1-2 contiguous vertebral levels * ECOG 0-2 * Negative serum or urine pregnancy test within 14 days prior to enrollment for people of childbearing potential or who are not postmenopausal * people of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control * Ability to understand and the willingness to sign (personally or by a legal authorized representative) the written IRB approv |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Stanford University |
| Locations | Palo Alto, California, United States |
| Start date | 2023-12-18 |
| NCT ID | NCT06173401 |
| Official listing | https://clinicaltrials.gov/study/NCT06173401 |